510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K843382Substantially Equivalent

Urocystin

Mission Pharmacal Company, San Antonio TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843382 is the FDA 510(k) clearance record for UROCYSTIN, a class I device, cleared for Mission Pharmacal Co. on under FDA product code JLC (Nitroprusside Reaction (Qualitative, Urine), Cystine). FDA records list 3 510(k) clearances for Mission Pharmacal Co., from to . As of , FDA records show no recalls naming K843382.

Clearance record

Decision date
Received
(133 days to decision)
Product code
JLC Nitroprusside Reaction (Qualitative, Urine), Cystine
Regulation
21 CFR 862.1240
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Mission Pharmacal Co. P.O. Box 1676, San Antonio TX
Third party review
No

Clearances, product code JLC

Trailing 12 months

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

FDA records show no clearances under product code JLC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JLC, 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