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FDA 510(k)

CARDIO REP CK ISOENZYME KIT - 3310

K-Number: K931050 · 1993-04-20

ApplicantHelena Laboratories
Decision Date1993-04-20
Product CodeJHW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARDIO REP CK ISOENZYME KIT - 3310 is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1993-04-20 under 510(k) number K931050. The device is classified under product code JHW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIO REP CK ISOENZYME KIT - 3310?

CARDIO REP CK ISOENZYME KIT - 3310 is a medical device that received FDA 510(k) clearance on 1993-04-20. The listed applicant is Helena Laboratories. The 510(k) number is K931050.

When did CARDIO REP CK ISOENZYME KIT - 3310 receive FDA 510(k) clearance?

CARDIO REP CK ISOENZYME KIT - 3310 received FDA 510(k) clearance on 1993-04-20, under 510(k) number K931050.

Who is the listed applicant for CARDIO REP CK ISOENZYME KIT - 3310?

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 CK ISOENZYME KIT - 3310?

The FDA product code for CARDIO REP CK ISOENZYME KIT - 3310 is JHW.

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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: JHW)

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.

K162526Creatine Kinase-MBRoche DiagnosticsK122083ELITECH CLINICAL SYSTEMS CK NAC SLElitechgroupK023744WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354Wiener Laboratories SaicK003158ROCHE DIAGNOSTICS CK-MBRoche Diagnostics Corp.K961501ELECSYS CK-MBBoehringer Mannheim Corp.K950186CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEMMiles, Inc.

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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