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FDA 510(k)

SHOT GUN KIT FOR CK-MB

K-Number: K831391 · 1983-11-04

ApplicantSerapine Corp.
Decision Date1983-11-04
Product CodeJHT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SHOT GUN KIT FOR CK-MB is the device name listed in this FDA 510(k) record. The listed applicant is Serapine Corp.. It received FDA 510(k) clearance on 1983-11-04 under 510(k) number K831391. 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 SHOT GUN KIT FOR CK-MB?

SHOT GUN KIT FOR CK-MB is a medical device that received FDA 510(k) clearance on 1983-11-04. The listed applicant is Serapine Corp.. The 510(k) number is K831391.

When did SHOT GUN KIT FOR CK-MB receive FDA 510(k) clearance?

SHOT GUN KIT FOR CK-MB received FDA 510(k) clearance on 1983-11-04, under 510(k) number K831391.

Who is the listed applicant for SHOT GUN KIT FOR CK-MB?

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

What is the FDA product code for SHOT GUN KIT FOR CK-MB?

The FDA product code for SHOT GUN KIT FOR CK-MB is JHT.

Related Devices (Code: JHT)

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.

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 LaboratoriesK904866COULTER 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

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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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