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

72 results for "Baxter Diagnostics, Inc."

49–72 of 72

Search insights Median review: 112d Cleared: 100% Top manufacturer: Baxter Diagnostics, Inc. Lead specialty: Microbiology

Cleared Sep 02, 1992

BARTELS TOXOPLASMA IGG EIA

Baxter Diagnostics, Inc.

Microbiology · 98d

Cleared Sep 02, 1992

BARTELS TOXOPLASMA IGM EIA

Baxter Diagnostics, Inc.

Microbiology · 98d

Cleared Sep 02, 1992

BARTELS LYME DISEASE IGM EIA

Baxter Diagnostics, Inc.

Microbiology · 98d

Cleared Sep 02, 1992

BARTELS RUBEOLA IGM EIA

Baxter Diagnostics, Inc.

Microbiology · 112d

Cleared Sep 02, 1992

BARTELS EPSTEIN-BARR VIRUS IGG EIA

Baxter Diagnostics, Inc.

Microbiology · 112d

Cleared Sep 02, 1992

BARTELS EPSTEIN-BARR VIRUS IGM EIA

Baxter Diagnostics, Inc.

Microbiology · 112d

Cleared Sep 02, 1992

BARTELS RUBEOLA IGG EIA

Baxter Diagnostics, Inc.

Microbiology · 112d

Cleared Aug 26, 1992

PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT

Baxter Diagnostics, Inc.

Chemistry · 40d

Cleared Jul 27, 1992

DADE RECOMBOPLASTIN S

Baxter Diagnostics, Inc.

Hematology · 131d

Cleared Jul 21, 1992

STRATUS MYOGLOBIN FLUOROMETRIC ENZYME IMMUNOASSAY

Baxter Diagnostics, Inc.

Immunology · 76d

Cleared Jul 15, 1992

DADE(R) MYOGLOBIN CONTROLS TRI-LEVEL

Baxter Diagnostics, Inc.

Immunology · 56d

Cleared Jul 07, 1992

DADE URINE CHEMISTRY CONTROL LEVELS I AND II

Baxter Diagnostics, Inc.

Chemistry · 146d

Cleared Jun 04, 1992

DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA

Baxter Diagnostics, Inc.

Hematology · 99d

Cleared May 22, 1992

APOLIPOPROTEIN TEST SYSTEM

Baxter Diagnostics, Inc.

Immunology · 79d

Cleared May 11, 1992

DADE IMMUNOADSORBED FACTOR IX DEFICIENT PLASMA

Baxter Diagnostics, Inc.

Hematology · 161d

Cleared Jan 15, 1992

DADE(R) ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO ASSAY

Baxter Diagnostics, Inc.

Hematology · 82d

Cleared Oct 11, 1991

BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE

Baxter Diagnostics, Inc.

Chemistry · 22d

Cleared Sep 27, 1991

BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO

Baxter Diagnostics, Inc.

Microbiology · 93d

Cleared Aug 29, 1991

BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN

Baxter Diagnostics, Inc.

Microbiology · 38d

Cleared Jul 22, 1991

ANTIGENZ CHLAMYDIA

Baxter Diagnostics, Inc.

Microbiology · 49d

Cleared Nov 22, 1988

PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT

Baxter Diagnostics, Inc.

Microbiology · 47d

Cleared Nov 22, 1988

PARAINFLUENZA TYPE 3 IFA TEST KIT FOR ANTI. DETECT

Baxter Diagnostics, Inc.

Microbiology · 47d

Cleared Nov 22, 1988

RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION

Baxter Diagnostics, Inc.

Microbiology · 47d

Cleared Nov 22, 1988

INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION

Baxter Diagnostics, Inc.

Microbiology · 47d