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FDA 510(k)

CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK)

K-Number: K960800 · 1996-07-26

ApplicantBoehringer Mannheim Corp.
Decision Date1996-07-26
Product CodeCGN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK) is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1996-07-26 under 510(k) number K960800. The device is classified under product code CGN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK)?

CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK) is a medical device that received FDA 510(k) clearance on 1996-07-26. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K960800.

When did CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK) receive FDA 510(k) clearance?

CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK) received FDA 510(k) clearance on 1996-07-26, under 510(k) number K960800.

Who is the listed applicant for CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK)?

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

What is the FDA product code for CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK)?

The FDA product code for CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK) is CGN.

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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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