510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K851278Substantially Equivalent

Acetazyme, Stanbio Acetaminophen Proc/test 0870

Stanbio Laboratory, San Antonio TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851278 is the FDA 510(k) clearance record for ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870, a class II device, cleared for Stanbio Laboratory on under FDA product code LDP (Colorimetry, Acetaminophen). FDA records list 47 510(k) clearances for Stanbio Laboratory, from to . As of , FDA records show no recalls naming K851278.

Clearance record

Decision date
Received
(16 days to decision)
Product code
LDP Colorimetry, Acetaminophen
Regulation
21 CFR 862.3030
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Stanbio Laboratory 2930 E. Houston St., San Antonio TX
Third party review
No

Clearances, product code LDP

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