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FDA 510(k)

CREATININE PAP

K-Number: K854766 · 1986-01-17

ApplicantBoehringer Mannheim Corp.
Decision Date1986-01-17
Product CodeJFY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATININE PAP 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 1986-01-17 under 510(k) number K854766. The device is classified under product code JFY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CREATININE PAP?

CREATININE PAP is a medical device that received FDA 510(k) clearance on 1986-01-17. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K854766.

When did CREATININE PAP receive FDA 510(k) clearance?

CREATININE PAP received FDA 510(k) clearance on 1986-01-17, under 510(k) number K854766.

Who is the listed applicant for CREATININE PAP?

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 CREATININE PAP?

The FDA product code for CREATININE PAP is JFY.

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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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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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