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FDA 510(k)

BM PRECIPATH(R) HDL/LDL-C CONTROL

K-Number: K974826 · 1998-01-22

ApplicantBoehringer Mannheim Corp.
Decision Date1998-01-22
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BM PRECIPATH(R) HDL/LDL-C CONTROL 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 1998-01-22 under 510(k) number K974826. 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 BM PRECIPATH(R) HDL/LDL-C CONTROL?

BM PRECIPATH(R) HDL/LDL-C CONTROL is a medical device that received FDA 510(k) clearance on 1998-01-22. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K974826.

When did BM PRECIPATH(R) HDL/LDL-C CONTROL receive FDA 510(k) clearance?

BM PRECIPATH(R) HDL/LDL-C CONTROL received FDA 510(k) clearance on 1998-01-22, under 510(k) number K974826.

Who is the listed applicant for BM PRECIPATH(R) HDL/LDL-C CONTROL?

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 BM PRECIPATH(R) HDL/LDL-C CONTROL?

The FDA product code for BM PRECIPATH(R) HDL/LDL-C CONTROL is JJY.

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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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