510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K873413Substantially Equivalent

Gram Crystal Violet/iodine/aceton Alchl Declr/safr

Lakewood Biochemical Co., Inc., Dallas TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K873413 is the FDA 510(k) clearance record for GRAM CRYSTAL VIOLET/IODINE/ACETON ALCHL DECLR/SAFR, a class I device, cleared for Lakewood Biochemical Co., Inc. on under FDA product code JTS (Stains, Microbiologic). FDA records list 89 510(k) clearances for Lakewood Biochemical Co., Inc., from to . As of , FDA records show no recalls naming K873413.

Clearance record

Decision date
Received
(43 days to decision)
Product code
JTS Stains, Microbiologic
Regulation
21 CFR 864.1850
Device class
Class I
Review panel
Hematology
Applicant
Lakewood Biochemical Co., Inc. 2111 Irving Blvd., Dallas TX
Third party review
No

Clearances, product code JTS

Trailing 12 months

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

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