BIOSCAN

Method, Enzymatic, Glucose (urinary, Non-quantitative)

BIOSYS LABORATORIES, INC.

The following data is part of a premarket notification filed by Biosys Laboratories, Inc. with the FDA for Bioscan.

Pre-market Notification Details

• Device ID: K952307
• 510k Number: K952307
• Device Name: BIOSCAN
• Classification: Method, Enzymatic, Glucose (urinary, Non-quantitative)
• Applicant: BIOSYS LABORATORIES, INC. 280 SOUTH ATLANTIC BLVD. Los Angeles, CA 90022
• Contact: William T Pih
• Correspondent: William T Pih; BIOSYS LABORATORIES, INC. 280 SOUTH ATLANTIC BLVD. Los Angeles, CA 90022
• Product Code: JIL
• Subsequent Product Code: CDM
• Subsequent Product Code: CEN
• Subsequent Product Code: JIN
• Subsequent Product Code: JIO
• Subsequent Product Code: JIR
• Subsequent Product Code: JJB
• Subsequent Product Code: JMA
• Subsequent Product Code: JMT
• Subsequent Product Code: JRE
• Subsequent Product Code: LJX
• CFR Regulation Number: 862.1340 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-05-17
• Decision Date: 1995-09-05

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08806125680156	K952307	000
08806125680071	K952307	000
08806125680286	K952307	000
08806125680279	K952307	000
08806125680217	K952307	000
08806125680064	K952307	000
08806125680033	K952307	000
08806125680019	K952307	000