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FDA 510(k)

CPK ISOENZYME CONTROL

K-Number: K770555 · 1977-06-03

ApplicantBio-Reagents & Diagnostics, Inc.
Decision Date1977-06-03
Product CodeJJT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CPK ISOENZYME CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Reagents & Diagnostics, Inc.. It received FDA 510(k) clearance on 1977-06-03 under 510(k) number K770555. The device is classified under product code JJT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CPK ISOENZYME CONTROL?

CPK ISOENZYME CONTROL is a medical device that received FDA 510(k) clearance on 1977-06-03. The listed applicant is Bio-Reagents & Diagnostics, Inc.. The 510(k) number is K770555.

When did CPK ISOENZYME CONTROL receive FDA 510(k) clearance?

CPK ISOENZYME CONTROL received FDA 510(k) clearance on 1977-06-03, under 510(k) number K770555.

Who is the listed applicant for CPK ISOENZYME CONTROL?

The FDA 510(k) record lists Bio-Reagents & Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CPK ISOENZYME CONTROL?

The FDA product code for CPK ISOENZYME CONTROL is JJT.

Related Clinical Trials

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Other records listing Bio-Reagents & Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K781702CALIBRATOR, BOVINE SERUMK771894LDH ISOENZYME CONTROLK760730ANTICONVULSANT CONTROL SERUM

Related Devices (Code: JJT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K090940SPOTCHECK BLOOD SPOT CONTROL, ASSAYEDAstoria-Pacific, Inc.K062751MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKERQuantimetrix Corp.K030768CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVELCliniqa CorporationK030102ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3Bayer Healthcare, LLCK021498LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVELBio-RadK012656LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648Bio-Rad

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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