Cleared Traditional

K820644 - RAICHEM TM CREATINE KINASE REAGENT

K820644 is the FDA 510(k) clearance for RAICHEM TM CREATINE KINASE REAGENT by Reagents Applications, Inc.. It is a Class 2 Chemistry device (product code CGS) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K820644 · Reagents Applications, Inc. · Chemistry device
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Apr 1982
Decision
23d
Days
Class 2
Risk

K820644 is an FDA 510(k) clearance for the RAICHEM TM CREATINE KINASE REAGENT. Classified as Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (product code CGS), Class II - Special Controls.

Submitted by Reagents Applications, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 1, 1982 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1215 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Reagents Applications, Inc. devices

Submission Details

510(k) Number K820644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1982
Decision Date April 01, 1982
Days to Decision 23 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 88d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGS Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1215
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CGS Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes

All 99
Devices cleared under the same product code (CGS) and FDA review panel - the closest regulatory comparables to K820644.
ULTRAZYME PLUS CK-I, #64978,65027&65028
K821460 · Emd Chemicals, Inc. · Jun 1982
LIQUID-STAT LIQUID ENZYME REAGENT
K821240 · Beckman Instruments, Inc. · May 1982
SERALYZER CK REAGENT STRIPS
K820880 · Miles Laboratories, Inc. · Apr 1982
ULTRA ZYME PLUS CK-1 #64978, 65027 & 28
K812593 · Harleco · Oct 1981
CARDIOZYME PLUS CK-TOTAL ITEM #65046
K811574 · Harleco · Jun 1981
CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A)
K811576 · Harleco · Jun 1981