Product Code: LJG FDA class 1 21 CFR 866.2660

Quality Control Slides

Microbiology

Quality control slides are prepared microscopy slides containing fixed reference material used to verify the performance of staining procedures, microscopes, and laboratory personnel skills in microbiology and pathology laboratories, ensuring consistent and reliable diagnostic results. The device is FDA Class 1, the lowest risk category, requiring only general controls and exempt from premarket notification. It carries product code LJG and is regulated under 21 CFR 866.2660 within the Microbiology specialty. No special flags apply to this device.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code LJG in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: LJG
Device Class: FDA class 1
Regulation Number: 866.2660
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 27 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K943228	MICROSPORIDIUM CONTROL SET	Oct 27, 1994	Substantially Equivalent	Meridian Diagnostics, Inc.
K924893	MICROSPORIDIUM CONTROL SLIDE	Jan 15, 1993	Substantially Equivalent	Scientific Device Laboratory, Inc.
K890718	GRAM STAIN CONTROL SLIDE	Mar 16, 1989	Substantially Equivalent	Scientific Device Laboratory, Inc.
K890670	CRYPTOSPORIDIUM CONTROL SLIDE	Mar 16, 1989	Substantially Equivalent	Scientific Device Laboratory, Inc.
K890616	BION DIRECT IDENTIFICATION CONTROL SLIDE	Feb 17, 1989	Substantially Equivalent	Bion Ent., Ltd.
K883571	HISTO-CHECK PARASITIC CONTROL SLIDES	Oct 06, 1988	Substantially Equivalent	Val Tech Diagnostics, Inc.
K883570	HISTO-CHECK FUNGAL CONTROL SLIDES	Oct 06, 1988	Substantially Equivalent	Val Tech Diagnostics, Inc.
K883569	HISTO-CHECK GRAM NEGATIVE SLIDES	Oct 06, 1988	Substantially Equivalent	Val Tech Diagnostics, Inc.
K883568	HISTO-CHECK ACID FAST SLIDES	Oct 06, 1988	Substantially Equivalent	Val Tech Diagnostics, Inc.
K883567	HISTO-CHECK LEGIONELLA CONTROL SLIDES	Oct 06, 1988	Substantially Equivalent	Val Tech Diagnostics, Inc.
K883208	HISTO-CHECK SLIDES	Aug 25, 1988	Substantially Equivalent	Val Tech Diagnostics, Inc.
K881112	FUNGI HISTOLOGY CONTROL SLIDES	Apr 21, 1988	Substantially Equivalent	Sigma Diagnostics, Inc.
K881109	SPIROCHETES HISTOLOGY CONTROL SLIDES	Apr 21, 1988	Substantially Equivalent	Sigma Diagnostics, Inc.
K881106	ACID FAST BACILLI HISTOLOGY CONTROL SLIDES	Apr 21, 1988	Substantially Equivalent	Sigma Diagnostics, Inc.
K881110	LEGIONELLA PNEUMOPHILLA HISTOLOGY CONTROL SLIDES	Apr 12, 1988	Substantially Equivalent	Sigma Diagnostics, Inc.
K881108	PNEUMOCYSTIS CARINII HISTOLOGY CONTROL SLIDES	Apr 12, 1988	Substantially Equivalent	Sigma Diagnostics, Inc.
K881111	INTRACELLULAR/EXTRACELLULAR IRON HISTOLOGY CONTROL	Mar 30, 1988	Substantially Equivalent	Sigma Diagnostics, Inc.
K881107	INTRACELLULAR AMYLOID HISTOLOGY CONTROL SLIDES	Mar 30, 1988	Substantially Equivalent	Sigma Diagnostics, Inc.
K880962	ATS CRYPTOSPORIDIUM STAIN CONTROL SLIDES	Mar 30, 1988	Substantially Equivalent	Alpha-Tec Systems, Inc.
K840517	PROTOZOA STAIN CONTROL	Mar 09, 1984	Substantially Equivalent	Scientific Device Laboratory, Inc.
K840516	METACHROMATIC GRANULE STAIN CONTROL	Mar 09, 1984	Substantially Equivalent	Scientific Device Laboratory, Inc.
K840515	ACID FAST BACILLI STAIN CONTROL	Mar 09, 1984	Substantially Equivalent	Scientific Device Laboratory, Inc.
K830134	Q-CHECK REAGENT STANDARDS	Jan 09, 1983	Substantially Equivalent	Lab Ability, Inc.
K823706	ATS AFB STAIN CONTROL SLIDE	Jan 07, 1983	Substantially Equivalent	Alpha-Tec Systems, Inc.
K823705	ATS PARASITOLOGY STAIN CONTROL SLIDE	Jan 07, 1983	Substantially Equivalent	Alpha-Tec Systems, Inc.
K823704	ATS GRAM STAIN CONTROL SLIDE	Jan 07, 1983	Substantially Equivalent	Alpha-Tec Systems, Inc.
K822604	ACID FAST QUALITY CONTROL SLIDES	Sep 28, 1982	Substantially Equivalent	Medastat Scientific Corp.