510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853236Substantially Equivalent

Apl Tsa with 5% Sheep Blood

Apl Medical Supplies, Las Vegas NV / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853236 is the FDA 510(k) clearance record for APL TSA WITH 5% SHEEP BLOOD, a class I device, cleared for Apl Medical Supplies on under FDA product code KZI (Culture Media, Enriched). FDA records list 25 510(k) clearances for Apl Medical Supplies, from to . As of , FDA records show no recalls naming K853236.

Clearance record

Decision date
Received
(18 days to decision)
Product code
KZI Culture Media, Enriched
Regulation
21 CFR 866.2330
Device class
Class I
Review panel
Microbiology
Applicant
Apl Medical Supplies 4230 S. Burnham Ave. #250, Las Vegas NV
Third party review
No

Clearances, product code KZI

Trailing 12 months

FDA records hold no clearances under product code KZI in the trailing twelve months.

FDA records show no clearances under product code KZI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KZI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260