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FDA 510(k)

PRECINORM U & PRECIPATH U HUMAN SERUM

K-Number: K811832 · 1981-07-15

ApplicantBoehringer Mannheim Corp.
Decision Date1981-07-15
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PRECINORM U & PRECIPATH U HUMAN SERUM 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 1981-07-15 under 510(k) number K811832. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRECINORM U & PRECIPATH U HUMAN SERUM?

PRECINORM U & PRECIPATH U HUMAN SERUM is a medical device that received FDA 510(k) clearance on 1981-07-15. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K811832.

When did PRECINORM U & PRECIPATH U HUMAN SERUM receive FDA 510(k) clearance?

PRECINORM U & PRECIPATH U HUMAN SERUM received FDA 510(k) clearance on 1981-07-15, under 510(k) number K811832.

Who is the listed applicant for PRECINORM U & PRECIPATH U HUMAN SERUM?

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 PRECINORM U & PRECIPATH U HUMAN SERUM?

The FDA product code for PRECINORM U & PRECIPATH U HUMAN SERUM is JJX.

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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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