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FDA 510(k)

PANTRAK E.K.

K-Number: K810669 · 1981-03-31

ApplicantCalbiochem-Behring Corp.
Decision Date1981-03-31
Product CodeCIW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PANTRAK E.K. is the device name listed in this FDA 510(k) record. The listed applicant is Calbiochem-Behring Corp.. It received FDA 510(k) clearance on 1981-03-31 under 510(k) number K810669. The device is classified under product code CIW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PANTRAK E.K.?

PANTRAK E.K. is a medical device that received FDA 510(k) clearance on 1981-03-31. The listed applicant is Calbiochem-Behring Corp.. The 510(k) number is K810669.

When did PANTRAK E.K. receive FDA 510(k) clearance?

PANTRAK E.K. received FDA 510(k) clearance on 1981-03-31, under 510(k) number K810669.

Who is the listed applicant for PANTRAK E.K.?

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

What is the FDA product code for PANTRAK E.K.?

The FDA product code for PANTRAK E.K. is CIW.

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Other records listing Calbiochem-Behring Corp. as applicant

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Related Devices (Code: CIW)

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K931559DMA AMYLASE PROCEDUREData Medical Associates, Inc.K924339OLYMPUS AMYLASE REAGENTOlympus Corp.K884382AMYLASE TEST (AMYL) ITEM NUMBER: 65653Em Diagnostic Systems, Inc.K850639ENZYMATIC ALPHA-AMYLASE REAGENT KITBio-Analytics Laboratories, Inc.K812027KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL)Eastman Kodak CompanyK810584PHADEBAS ISOAMYLASE TESTPharmacia, 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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