510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K903308Substantially Equivalent

Transtat-Cmv(tm)

Ab Sangtec Medical, Menlo Park CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903308 is the FDA 510(k) clearance record for TRANSTAT-CMV(TM), a class II device, cleared for Ab Sangtec Medical on under FDA product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella). FDA records list one 510(k) clearance for Ab Sangtec Medical. As of , FDA records show no recalls naming K903308.

Clearance record

Decision date
Received
(133 days to decision)
Product code
LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Regulation
21 CFR 866.3510
Device class
Class II
Review panel
Microbiology
Applicant
Ab Sangtec Medical 3603-D Haven Ave., Menlo Park CA
Third party review
No

Clearances, product code LFX

Trailing 12 months
1 clearance under product code LFX in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LFX, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260