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FDA 510(k)

DIAGNOSTICS HDL CHOLESTEROL PRECIPITANT

K-Number: K821852 · 1982-07-02

ApplicantBoehringer Mannheim Corp.
Decision Date1982-07-02
Product Code
DecisionSubstantially Equivalent

Device Summary

DIAGNOSTICS HDL CHOLESTEROL PRECIPITANT 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 1982-07-02 under 510(k) number K821852. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAGNOSTICS HDL CHOLESTEROL PRECIPITANT?

DIAGNOSTICS HDL CHOLESTEROL PRECIPITANT is a medical device that received FDA 510(k) clearance on 1982-07-02. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K821852.

When did DIAGNOSTICS HDL CHOLESTEROL PRECIPITANT receive FDA 510(k) clearance?

DIAGNOSTICS HDL CHOLESTEROL PRECIPITANT received FDA 510(k) clearance on 1982-07-02, under 510(k) number K821852.

Who is the listed applicant for DIAGNOSTICS HDL CHOLESTEROL PRECIPITANT?

The FDA 510(k) record lists Boehringer Mannheim Corp. as the applicant. This does not by itself establish the device manufacturer.

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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.

K984326ELECYS IGE ASSAYK983047ACCU-CHEK HQ SYSTEMK984419ELECSYS IGE CALCHECKK984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATORK984372ELECSYS CALCHECK TROPONIN TK984105ELECSYS TROPONIN T STAT TEST

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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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