510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K122064Substantially Equivalent

Forsure One Step Buprenorphine Cup Test Device

Tianjin New Bay Bioresearch Co., Ltd., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K122064 is the FDA 510(k) clearance record for FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE, a class II device, cleared for Tianjin New Bay Bioresearch Co., Ltd. on under FDA product code DJG (Enzyme Immunoassay, Opiates). FDA records list 11 510(k) clearances for Tianjin New Bay Bioresearch Co., Ltd., from to . As of , FDA records show no recalls naming K122064.

Clearance record

Decision date
Received
(298 days to decision)
Product code
DJG Enzyme Immunoassay, Opiates
Regulation
21 CFR 862.3650
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Tianjin New Bay Bioresearch Co., Ltd. 4455 Murphy Canyon Rd., Suite 204, San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DJG

Trailing 12 months
3 clearances under product code DJG in the twelve months to October 2026, January 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DJG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20263
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260