510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961548Substantially Equivalent

Sas Shigella Boydii Type 15 Antiserum

SA Scientific, Ltd, San Antonio TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961548 is the FDA 510(k) clearance record for SAS SHIGELLA BOYDII TYPE 15 ANTISERUM, a class II device, cleared for Sa Scientific, Inc. on under FDA product code GNB (Antisera, All Types, Shigella Spp.). FDA records list 201 510(k) clearances for Sa Scientific, Inc., from to . As of , FDA records show no recalls naming K961548.

Clearance record

Decision date
Received
(28 days to decision)
Product code
GNB Antisera, All Types, Shigella Spp.
Regulation
21 CFR 866.3660
Device class
Class II
Review panel
Microbiology
Applicant
Sa Scientific, Inc. 4919 Golden Quail, San Antonio TX
510(k) summary
Statement
Third party review
No

Clearances, product code GNB

Trailing 12 months

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

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