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FDA 510(k)

PRECINORM(R) IM NORMAL IMMUNOASSAY CONTROL SERUM

K-Number: K902536 · 1990-07-10

ApplicantBoehringer Mannheim Corp.
Decision Date1990-07-10
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PRECINORM(R) IM NORMAL IMMUNOASSAY CONTROL 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 1990-07-10 under 510(k) number K902536. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRECINORM(R) IM NORMAL IMMUNOASSAY CONTROL SERUM?

PRECINORM(R) IM NORMAL IMMUNOASSAY CONTROL SERUM is a medical device that received FDA 510(k) clearance on 1990-07-10. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K902536.

When did PRECINORM(R) IM NORMAL IMMUNOASSAY CONTROL SERUM receive FDA 510(k) clearance?

PRECINORM(R) IM NORMAL IMMUNOASSAY CONTROL SERUM received FDA 510(k) clearance on 1990-07-10, under 510(k) number K902536.

Who is the listed applicant for PRECINORM(R) IM NORMAL IMMUNOASSAY CONTROL 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(R) IM NORMAL IMMUNOASSAY CONTROL SERUM?

The FDA product code for PRECINORM(R) IM NORMAL IMMUNOASSAY CONTROL SERUM is JJY.

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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.

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Related Devices (Code: JJY)

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.

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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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