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FDA 510(k)

SPECIAL CONTROL SERUM FOR HDL-CHOLES

K-Number: K823196 · 1982-11-29

ApplicantBoehringer Mannheim Corp.
Decision Date1982-11-29
Product CodeJJK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SPECIAL CONTROL SERUM FOR HDL-CHOLES 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 1982-11-29 under 510(k) number K823196. The device is classified under product code JJK. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECIAL CONTROL SERUM FOR HDL-CHOLES?

SPECIAL CONTROL SERUM FOR HDL-CHOLES is a medical device that received FDA 510(k) clearance on 1982-11-29. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K823196.

When did SPECIAL CONTROL SERUM FOR HDL-CHOLES receive FDA 510(k) clearance?

SPECIAL CONTROL SERUM FOR HDL-CHOLES received FDA 510(k) clearance on 1982-11-29, under 510(k) number K823196.

Who is the listed applicant for SPECIAL CONTROL SERUM FOR HDL-CHOLES?

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 SPECIAL CONTROL SERUM FOR HDL-CHOLES?

The FDA product code for SPECIAL CONTROL SERUM FOR HDL-CHOLES is JJK.

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Other records listing Boehringer Mannheim Corp. as applicant

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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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