Tool · 510(k)

510(k) Predicate Finder

Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

Product Code: JSG FDA class 1

Culture Media, Non-Selective And Non-Differential

Microbiology

View full classification →

The Culture Media, Non-Selective and Non-Differential is a microbiology diagnostic medium that supports the growth of a broad range of microorganisms without inhibiting or distinguishing between organism types, used in clinical laboratories as a general growth medium for primary culture and subculture of clinical specimens. This device is FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. It carries product code JSG and is regulated under 21 CFR 866.2300, within the Microbiology medical specialty.

510(k) Clearances

50+ matches

K Number

Device Name

Decision Date

Decision

Applicant

K882495

THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007

Jul 01, 1988

Substantially Equivalent

LAKEWOOD BIOCHEMICAL CO., INC.

K881525

COOKED MEAT MEDIUM

Apr 18, 1988

Substantially Equivalent

ACUMEDIA MANUFACTURERS, INC.

K881558

TRYPTOSE AGAR

Apr 18, 1988

Substantially Equivalent

ACUMEDIA MANUFACTURERS, INC.

K881557

TRYPTONE

Apr 18, 1988

Substantially Equivalent

ACUMEDIA MANUFACTURERS, INC.

K881542

HEART INFUSION AGAR

Apr 18, 1988

Substantially Equivalent

ACUMEDIA MANUFACTURERS, INC.

K881528

CASEIN PEPTONE, LOW VITAMIN

Apr 18, 1988

Substantially Equivalent

ACUMEDIA MANUFACTURERS, INC.

K881546

MALT EXTRACT AGAR

Apr 18, 1988

Substantially Equivalent

ACUMEDIA MANUFACTURERS, INC.

K881564

TRYPTOSE BLOOD AGAR BASE W/YEAST EXTRACT

Apr 18, 1988

Substantially Equivalent

ACUMEDIA MANUFACTURERS, INC.

K881523

DEXTROSE TRYPTONE BROTH

Apr 18, 1988

Substantially Equivalent

ACUMEDIA MANUFACTURERS, INC.

K881548

MPH AGAR

Apr 18, 1988

Substantially Equivalent

ACUMEDIA MANUFACTURERS, INC.

K881554

SKIM MILK DEHYDRATED

Apr 18, 1988

Substantially Equivalent

ACUMEDIA MANUFACTURERS, INC.

K881531

BLOOD AGAR BASE, IMPROVED

Apr 18, 1988

Substantially Equivalent

ACUMEDIA MANUFACTURERS, INC.

K881522

DEXTROSE AGAR

Apr 18, 1988

Substantially Equivalent

ACUMEDIA MANUFACTURERS, INC.

K881543

LETHEEN AGAR

Apr 18, 1988

Substantially Equivalent

ACUMEDIA MANUFACTURERS, INC.

K881532

BLOOD AGAR BASE W/LOW PH

Apr 18, 1988

Substantially Equivalent

ACUMEDIA MANUFACTURERS, INC.

K881563

TRYPTOSE PHOSPHATE BROTH

Apr 18, 1988

Substantially Equivalent

ACUMEDIA MANUFACTURERS, INC.

K881550

OF BASAL MEDIUM

Apr 18, 1988

Substantially Equivalent

ACUMEDIA MANUFACTURERS, INC.

K881533

BLOOD AGAR BASE NO. 2

Apr 18, 1988

Substantially Equivalent

ACUMEDIA MANUFACTURERS, INC.

K881545

MALT EXTRACT

Apr 18, 1988

Substantially Equivalent

ACUMEDIA MANUFACTURERS, INC.

K881541

GELATIN

Apr 18, 1988

Substantially Equivalent

ACUMEDIA MANUFACTURERS, INC.

K881562

TRYPTOSE BLOOD AGAR BASE

Apr 18, 1988

Substantially Equivalent

ACUMEDIA MANUFACTURERS, INC.

K880947

NUTRIENT AGAR PLATE, SLANT TUBE AND BROTH TUBE

Apr 01, 1988

Substantially Equivalent

LAKEWOOD BIOCHEMICAL CO., INC.

K880142

TSA W/LEC. & TWEEN. 80

Mar 30, 1988

Substantially Equivalent

HARDY MEDIA

K881115

BACTEC(R) NR26 AND BACTEC(R) NR 27 CULTURE MEDIA

Mar 24, 1988

Substantially Equivalent

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

K880114

NUTRIENT BROTH

Mar 08, 1988

Substantially Equivalent

HARDY MEDIA

K875259

BITEK(TM) BLOOD CULTURE SYSTEM

Jan 27, 1988

Substantially Equivalent

DEFINITIVE DIAGNOSTICS, INC.

K875273

BITEK(TM) BLOOD CULTURE SYSTEM

Jan 22, 1988

Substantially Equivalent

DEFINITIVE DIAGNOSTICS, INC.

K875136

COLUMBIA BLOOD AGAR P3308/ COLUMBIA CNA P3750

Jan 12, 1988

Substantially Equivalent

LAKEWOOD BIOCHEMICAL CO., INC.

K874538

TODD-HEWITT BROTH (0.5ML)#3099 & (5.OML)#T3516

Nov 20, 1987

Substantially Equivalent

LAKEWOOD BIOCHEMICAL CO., INC.

K873257

GENERAL PURPOSE MEDIA W/SELECT. & DIFF. MODIFICA.

Nov 06, 1987

Substantially Equivalent

CENTRAL MEDIA

K873480

TSA 5% SHEEP BLOOD/EMB AGAR - PRODUCT #Z3023

Oct 08, 1987

Substantially Equivalent

LAKEWOOD BIOCHEMICAL CO., INC.

K873482

TSA 5% SHEEP BLOOD (SB)/MACCONKEY AGAR #Z3033

Oct 08, 1987

Substantially Equivalent

LAKEWOOD BIOCHEMICAL CO., INC.

K873483

TSA 5% SHEEP BLOOD (SB)/LEVINE EMB AGAR #Z3020

Oct 08, 1987

Substantially Equivalent

LAKEWOOD BIOCHEMICAL CO., INC.

K873325

SABOURAUD DEXTROSE SD EMMONS MOD. AGAR SLT TUBE

Oct 02, 1987

Substantially Equivalent

LAKEWOOD BIOCHEMICAL CO., INC.

K873328

SABOURAUD DEXTROSE - EMMONS AGAR PLATE #P3252

Oct 02, 1987

Substantially Equivalent

LAKEWOOD BIOCHEMICAL CO., INC.

K873222

BRAIN HEART INFUSION BROTH W/X AND V - #T4540

Sep 23, 1987

Substantially Equivalent

LAKEWOOD BIOCHEMICAL CO., INC.

K873217

BRAIN HEART INFUSION BROTH 10 ML - PRODUCT #T3006

Sep 23, 1987

Substantially Equivalent

LAKEWOOD BIOCHEMICAL CO., INC.

K873219

BRAIN HEART INFUSION BROTH 0.5 ML - PRODUCT #T3583

Sep 23, 1987

Substantially Equivalent

LAKEWOOD BIOCHEMICAL CO., INC.

K873220

BRAIN HEART INFUSION BROTH 4.5 ML - PRODUCT #T3003

Sep 23, 1987

Substantially Equivalent

LAKEWOOD BIOCHEMICAL CO., INC.

K873221

BRAIN HEART INFUSION AGAR W/5% SB - PRODUCT #P3409

Sep 23, 1987

Substantially Equivalent

LAKEWOOD BIOCHEMICAL CO., INC.

K873235

BRAIN HEART INFUSION AGAR POUR TUBE, - #T3004

Sep 22, 1987

Substantially Equivalent

LAKEWOOD BIOCHEMICAL CO., INC.

K873243

BRAIN HEART INFUS AGAR SLT W/5% SHEEP BLOOD #T3286

Sep 22, 1987

Substantially Equivalent

LAKEWOOD BIOCHEMICAL CO., INC.

K873236

BRAIN HEART INFUSION AGAR SLANT TUBE, - #T2904

Sep 22, 1987

Substantially Equivalent

LAKEWOOD BIOCHEMICAL CO., INC.

K873232

BRAIN HEART INFUSION AGAR - BHIA PRODUCT #P3302

Sep 18, 1987

Substantially Equivalent

LAKEWOOD BIOCHEMICAL CO., INC.

K873053

TRYPTIC SOY AGAR (TSA - PRODUCT #P2802)

Aug 24, 1987

Substantially Equivalent

LAKEWOOD BIOCHEMICAL CO., INC.

K873059

TRYPTIC SOY AGAR (TSA) SLANT - PRODUCT #T8765 11ML

Aug 24, 1987

Substantially Equivalent

LAKEWOOD BIOCHEMICAL CO., INC.

K873062

TRYPTIC SOY AGAR POUR TUBE - PRODUCT #T9172

Aug 24, 1987

Substantially Equivalent

LAKEWOOD BIOCHEMICAL CO., INC.

K873057

TRYPTIC SOY AGAR (TSA) SLANT - PRODUCT #T8903 7ML

Aug 24, 1987

Substantially Equivalent

LAKEWOOD BIOCHEMICAL CO., INC.

K872681

IAFP C.D.C. ANAEROBIC AGAR W/5% SHEEP BLOOD

Aug 11, 1987

Substantially Equivalent

I.A.F. PRODUCTION, INC.

K872677

IAFP B.H.I. AGAR

Aug 07, 1987

Substantially Equivalent

I.A.F. PRODUCTION, INC.

What is a Predicate Device?

A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

Popular Product Codes

Commonly searched

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