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FDA 510(k)

PRECINORM(R) PROTEIN

K-Number: K871027 · 1987-05-15

ApplicantBoehringer Mannheim Corp.
Decision Date1987-05-15
Product CodeDAF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

PRECINORM(R) PROTEIN 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 1987-05-15 under 510(k) number K871027. The device is classified under product code DAF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRECINORM(R) PROTEIN?

PRECINORM(R) PROTEIN is a medical device that received FDA 510(k) clearance on 1987-05-15. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K871027.

When did PRECINORM(R) PROTEIN receive FDA 510(k) clearance?

PRECINORM(R) PROTEIN received FDA 510(k) clearance on 1987-05-15, under 510(k) number K871027.

Who is the listed applicant for PRECINORM(R) PROTEIN?

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(R) PROTEIN?

The FDA product code for PRECINORM(R) PROTEIN is DAF.

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Other records listing Boehringer Mannheim Corp. as applicant

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.

K984326ELECYS IGE ASSAYK983047ACCU-CHEK HQ SYSTEMK984419ELECSYS IGE CALCHECKK984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATORK984372ELECSYS CALCHECK TROPONIN TK984105ELECSYS TROPONIN T STAT TEST

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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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