510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K852987Substantially Equivalent

Cariescreen - Sm

Pharma-Medica of Scandinavia, Ltd., Ontario L3r 2s2 Canada, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852987 is the FDA 510(k) clearance record for CARIESCREEN - SM, a class I device, cleared for Pharma-Medica of Scandinavia, Ltd. on under FDA product code JSJ (Culture Media, Selective And Non-Differential). FDA records list 2 510(k) clearances for Pharma-Medica of Scandinavia, Ltd., from to . As of , FDA records show no recalls naming K852987.

Clearance record

Decision date
Received
(35 days to decision)
Product code
JSJ Culture Media, Selective And Non-Differential
Regulation
21 CFR 866.2360
Device class
Class I
Review panel
Microbiology
Applicant
Pharma-Medica of Scandinavia, Ltd. 91 Esna Park Dr., Unit 2, Ontario L3r 2s2 Canada, CA
Third party review
No

Clearances, product code JSJ

Trailing 12 months

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

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