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FDA 510(k)

CARDIO REP RECOMBINANT CK ABNORMAL CONTROL

K-Number: K932442 · 1993-10-28

ApplicantHelena Laboratories
Decision Date1993-10-28
Product CodeJJT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARDIO REP RECOMBINANT CK ABNORMAL CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1993-10-28 under 510(k) number K932442. 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 CARDIO REP RECOMBINANT CK ABNORMAL CONTROL?

CARDIO REP RECOMBINANT CK ABNORMAL CONTROL is a medical device that received FDA 510(k) clearance on 1993-10-28. The listed applicant is Helena Laboratories. The 510(k) number is K932442.

When did CARDIO REP RECOMBINANT CK ABNORMAL CONTROL receive FDA 510(k) clearance?

CARDIO REP RECOMBINANT CK ABNORMAL CONTROL received FDA 510(k) clearance on 1993-10-28, under 510(k) number K932442.

Who is the listed applicant for CARDIO REP RECOMBINANT CK ABNORMAL CONTROL?

The FDA 510(k) record lists Helena Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIO REP RECOMBINANT CK ABNORMAL CONTROL?

The FDA product code for CARDIO REP RECOMBINANT CK ABNORMAL CONTROL is JJT.

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Other records listing Helena Laboratories 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.

K131479V8 SP NORMAL CONTROL, ABNORMAL CONTROLK100103SPECIALTY ASSAYED CONTROL-2K061991PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACAK061069SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458K061014ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LPK050053HEMORAM/AGGRAM ANALYZER

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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

View on FDA Database →

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

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