Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

39 results for "Vitek Systems, Inc."
25–39 of 39
Search insights Median review: 85d Cleared: 100% Top manufacturer: Vitek Systems, Inc. Lead specialty: Microbiology
Cleared Jun 16, 1988
VITEK YEAST BIOCHEMICAL CARD
K881925 · JXB
Vitek Systems, Inc.
Microbiology · 38d
Cleared Dec 12, 1984
AMS ANA CARD
K843686 · JSP
Vitek Systems, Inc.
Microbiology · 85d
Cleared Jul 20, 1984
GNC PLUS
K842587 · JTO
Vitek Systems, Inc.
Microbiology · 17d
Cleared Mar 09, 1984
AMS GRAM-POSITIVE IDENT. CARD
K834389 · JTO
Vitek Systems, Inc.
Microbiology · 86d
Cleared Mar 09, 1984
AMS GRAM-NEGATIVE IDENT. CARD
K834269 · JTO
Vitek Systems, Inc.
Microbiology · 92d
Cleared May 03, 1982
AMS GRAM-POSITIVE IDENTIFICATION CARD
K820264 · JTO
Vitek Systems, Inc.
Microbiology · 90d
Cleared Dec 19, 1979
AMS YEAST BIOCHEMICAL CARD
K792231 · JXB
Vitek Systems, Inc.
Microbiology · 44d
Cleared Nov 13, 1979
AMS ENTEROBACTERIACEASE CARE
K791932 · JSS
Vitek Systems, Inc.
Microbiology · 47d
Cleared Jan 26, 1979
CORD, ENTEROBACTERIACEAE BIOCHEMICAL
K782056 · JSS
Vitek Systems, Inc.
Microbiology · 46d
Cleared Jan 17, 1979
LIDOCAINE CALIBRATOR KIT
K780731 · DLJ
Vitek Systems, Inc.
Toxicology · 260d
Cleared Dec 07, 1978
THEOPHYLLINE CONTROL SERUM
K780961 · LAS
Vitek Systems, Inc.
Toxicology · 178d
Cleared Dec 07, 1978
SERUM, CONTROL, DRUGS, ANTIARRYTHMIC
K780960 · DIF
Vitek Systems, Inc.
Toxicology · 178d
Cleared Nov 22, 1978
PROCAINAMIDE CALIBRATOR KIT
K780732 · DLJ
Vitek Systems, Inc.
Toxicology · 204d
Cleared Jun 22, 1978
ANTICONVULSANTS II CALIBRATOR KIT
K780734 · DIY
Vitek Systems, Inc.
Toxicology · 51d
Cleared Jun 22, 1978
ANTICONVULSANTS III CALIBRATOR KIT
K780733 · DKH
Vitek Systems, Inc.
Toxicology · 51d