FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

METER, IV PH, MODEL ZEROMATIC

K Number: K770351 · Decision Apr 5, 1977
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
7
Applicant Total
281
Review Days
42

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Basic Information

Device Name
METER, IV PH, MODEL ZEROMATIC
K Number
K770351
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
862.2050
Medical Specialty
Clinical Chemistry
Decision
Substantially Equivalent
Applicant
Beckman Instruments, Inc.
Date Received
February 22, 1977
Decision Date
April 5, 1977
Product Code
JQY
Advisory Committee
Clinical Chemistry
Review Advisory Committee
CH
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
JQY Ph Meter

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K981403 IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT
K981354 ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211
K980173 ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505
K974816 ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229
K974564 IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT
K974110 IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT
K974452 VIGIL LIPID CONTROL
K973932 BECKMAN CALIBRATOR 2 (CAL2)
Search all 281 clearances from Beckman Instruments, Inc. →