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FDA 510(k)

REFLOMAT/REFLOTEST SYSTEM

K-Number: K761148 · 1977-02-11

ApplicantBoehringer Mannheim Corp.
Decision Date1977-02-11
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REFLOMAT/REFLOTEST SYSTEM 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 1977-02-11 under 510(k) number K761148. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REFLOMAT/REFLOTEST SYSTEM?

REFLOMAT/REFLOTEST SYSTEM is a medical device that received FDA 510(k) clearance on 1977-02-11. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K761148.

When did REFLOMAT/REFLOTEST SYSTEM receive FDA 510(k) clearance?

REFLOMAT/REFLOTEST SYSTEM received FDA 510(k) clearance on 1977-02-11, under 510(k) number K761148.

Who is the listed applicant for REFLOMAT/REFLOTEST SYSTEM?

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 REFLOMAT/REFLOTEST SYSTEM?

The FDA product code for REFLOMAT/REFLOTEST SYSTEM is CGA.

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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.

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Related Devices (Code: CGA)

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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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