FDA 510(k)

CK-ISOZYME U.V. REAGENT SET

K-Number: K823550 · 1983-01-07

Decision Date1983-01-07

Product CodeJHT

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

CK-ISOZYME U.V. REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Gelman Sciences, Inc.. It received FDA 510(k) clearance on 1983-01-07 under 510(k) number K823550. The device is classified under product code JHT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CK-ISOZYME U.V. REAGENT SET?

CK-ISOZYME U.V. REAGENT SET is a medical device that received FDA 510(k) clearance on 1983-01-07. The listed applicant is Gelman Sciences, Inc.. The 510(k) number is K823550.

When did CK-ISOZYME U.V. REAGENT SET receive FDA 510(k) clearance?

CK-ISOZYME U.V. REAGENT SET received FDA 510(k) clearance on 1983-01-07, under 510(k) number K823550.

Who is the listed applicant for CK-ISOZYME U.V. REAGENT SET?

The FDA 510(k) record lists Gelman Sciences, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CK-ISOZYME U.V. REAGENT SET?

The FDA product code for CK-ISOZYME U.V. REAGENT SET is JHT.

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Other records listing Gelman Sciences, Inc. as applicant

K946190DRUG DISPENSING SPIKE K943127PHARMASSURE LARGE VOLUME TRANSFER FILTERS K941589SYRINGE FILTER DEVICES K941020DRUG RECONSTITUTION FILTER DEVICE K942275VIAL VENT FILTER K941032UNKNOWN

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Related Devices (Code: JHT)

K022409SPECTRAL'S CARDIAC STATUS CK-MB RAPID TESTSpectral Diagnostics, Inc.K991299MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBIPrinceton BioMeditech Corp.K930359CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305Helena Laboratories K904866COULTER CK-MB ISOENZYME REAGENTCoulter Electronics, Inc.K904721DSL CK-MB (DSL #3200)Diagnostic Systems Laboratories, Inc.K901450MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MBIntl. Immunoassay Laboratories, 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.