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FDA 510(k)

BOEHRINGER MANNHEIM C.F.A.S. - HDL/LDL-C-PLUS

K-Number: K974825 · 1998-01-30

ApplicantBoehringer Mannheim Corp.
Decision Date1998-01-30
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BOEHRINGER MANNHEIM C.F.A.S. - HDL/LDL-C-PLUS 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 1998-01-30 under 510(k) number K974825. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOEHRINGER MANNHEIM C.F.A.S. - HDL/LDL-C-PLUS?

BOEHRINGER MANNHEIM C.F.A.S. - HDL/LDL-C-PLUS is a medical device that received FDA 510(k) clearance on 1998-01-30. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K974825.

When did BOEHRINGER MANNHEIM C.F.A.S. - HDL/LDL-C-PLUS receive FDA 510(k) clearance?

BOEHRINGER MANNHEIM C.F.A.S. - HDL/LDL-C-PLUS received FDA 510(k) clearance on 1998-01-30, under 510(k) number K974825.

Who is the listed applicant for BOEHRINGER MANNHEIM C.F.A.S. - HDL/LDL-C-PLUS?

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 BOEHRINGER MANNHEIM C.F.A.S. - HDL/LDL-C-PLUS?

The FDA product code for BOEHRINGER MANNHEIM C.F.A.S. - HDL/LDL-C-PLUS is JIX.

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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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