FDA 510(k)

BIO SCAN-BG(TM

K-Number: K910692 · 1991-03-29

Decision Date1991-03-29

Product CodeCGA

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

BIO SCAN-BG(TM is the device name listed in this FDA 510(k) record. The listed applicant is Bio Scan Instrument, Inc.. It received FDA 510(k) clearance on 1991-03-29 under 510(k) number K910692. 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 BIO SCAN-BG(TM?

BIO SCAN-BG(TM is a medical device that received FDA 510(k) clearance on 1991-03-29. The listed applicant is Bio Scan Instrument, Inc.. The 510(k) number is K910692.

When did BIO SCAN-BG(TM receive FDA 510(k) clearance?

BIO SCAN-BG(TM received FDA 510(k) clearance on 1991-03-29, under 510(k) number K910692.

Who is the listed applicant for BIO SCAN-BG(TM?

The FDA 510(k) record lists Bio Scan Instrument, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIO SCAN-BG(TM?

The FDA product code for BIO SCAN-BG(TM is CGA.

Related Devices (Code: CGA)

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.

K252488ABL90 FLEX PLUS SystemRadiometer Medicals Aps K210933YSI 2900C Biochemistry AnalyzerYsi, Inc.K220328EasyStat 300Medica Corporation K223179Cholestech LDX ™ SystemAlere San Diego, Inc.K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, 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.