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FDA 510(k)

PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL

K-Number: K902220 · 1990-09-05

ApplicantBoehringer Mannheim Corp.
Decision Date1990-09-05
Product CodeDGR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. 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 1990-09-05 under 510(k) number K902220. The device is classified under product code DGR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL?

PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL is a medical device that received FDA 510(k) clearance on 1990-09-05. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K902220.

When did PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL receive FDA 510(k) clearance?

PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL received FDA 510(k) clearance on 1990-09-05, under 510(k) number K902220.

Who is the listed applicant for PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. 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 PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL?

The FDA product code for PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL is DGR.

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Other records listing Boehringer Mannheim Corp. as applicant

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Related Devices (Code: DGR)

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.

K961544QUALITROL IGAME CONTROLS, LEVELS 1 AND 2Consolidated Technologies, Inc.K865014LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & IIBio-RadK790298RADIOASSAY, CONTROL SERUM I, II, IIIKallestad Laboratories, Inc.K781355ICS NORMAL CONTROL SERUMBeckman Instruments, Inc.

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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