510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K910692Substantially Equivalent

Bio Scan-Bg(tm

Bio Scan Instrument, Inc., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910692 is the FDA 510(k) clearance record for BIO SCAN-BG(TM, a class II device, cleared for Bio Scan Instrument, Inc. on under FDA product code CGA (Glucose Oxidase, Glucose). FDA records list one 510(k) clearance for Bio Scan Instrument, Inc. As of , FDA records show no recalls naming K910692.

Clearance record

Decision date
Received
(38 days to decision)
Product code
CGA Glucose Oxidase, Glucose
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Bio Scan Instrument, Inc. 39w 32nd St., New York NY
Third party review
No

Clearances, product code CGA

Trailing 12 months
1 clearance under product code CGA in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CGA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260