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FDA 510(k)

HCT CENTRIFUGE

K-Number: K822445 · 1982-09-14

ApplicantBoehringer Mannheim Corp.
Decision Date1982-09-14
Product CodeGKG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HCT CENTRIFUGE 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 1982-09-14 under 510(k) number K822445. The device is classified under product code GKG. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HCT CENTRIFUGE?

HCT CENTRIFUGE is a medical device that received FDA 510(k) clearance on 1982-09-14. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K822445.

When did HCT CENTRIFUGE receive FDA 510(k) clearance?

HCT CENTRIFUGE received FDA 510(k) clearance on 1982-09-14, under 510(k) number K822445.

Who is the listed applicant for HCT CENTRIFUGE?

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 HCT CENTRIFUGE?

The FDA product code for HCT CENTRIFUGE is GKG.

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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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Related Devices (Code: GKG)

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.

K961803SPUNCRIT (MODEL DRC-40)Micro Diagnostics Corp.K955795MULTI-CENTRIFUGENovonx, Inc.K930415MICROHEMATOCRIT ROTORFisher Scientific Co., LLCK925863SPUNCRITbioMerieux, Inc.K920207HERMLE Z230HLabnet Intl., Inc.K920759CRITSPIN MICRO-HEMATOCRITStat-Spin Technologies

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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