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."
25–48 of 72
Search insights Median review: 112d Cleared: 100% Top manufacturer: Baxter Diagnostics, Inc. Lead specialty: Microbiology
Cleared Oct 28, 1993
STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC
K932912 · CEC
Baxter Diagnostics, Inc.
Chemistry · 134d
Cleared Oct 22, 1993
STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY
K933464 · CHP
Baxter Diagnostics, Inc.
Chemistry · 98d
Cleared Oct 08, 1993
STRATUS PROGESTERONE FLOUROMETRIC IMMUNOASSAY
K933635 · JLS
Baxter Diagnostics, Inc.
Chemistry · 73d
Cleared Sep 24, 1993
DADE URINE CHEMISTRY CONTROL, LEVEL 1 & LEVEL 2
K933435 · JJY
Baxter Diagnostics, Inc.
Chemistry · 72d
Cleared Sep 24, 1993
PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS
K932685 · KLS
Baxter Diagnostics, Inc.
Toxicology · 113d
Cleared Sep 22, 1993
DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI
K933188 · JPA
Baxter Diagnostics, Inc.
Hematology · 84d
Cleared Aug 26, 1993
STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO
K933426 · CDX
Baxter Diagnostics, Inc.
Chemistry · 44d
Cleared Aug 05, 1993
DADE(R) TUMOR MARKER CONTROL
K924919 · JJY
Baxter Diagnostics, Inc.
Immunology · 310d
Cleared Jul 20, 1993
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
K932082 · JWY
Baxter Diagnostics, Inc.
Microbiology · 81d
Cleared Apr 08, 1993
BARTELS CYTOMEGALOVIRUS IGG EIA
K922582 · LFZ
Baxter Diagnostics, Inc.
Microbiology · 316d
Cleared Apr 08, 1993
BARTELS CYTOMEGALOVIRUS IGM EIA
K922580 · LKQ
Baxter Diagnostics, Inc.
Microbiology · 316d
Cleared Mar 26, 1993
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
K926545 · JWY
Baxter Diagnostics, Inc.
Microbiology · 85d
Cleared Mar 12, 1993
MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL
K922482 · LRG
Baxter Diagnostics, Inc.
Microbiology · 289d
Cleared Jan 11, 1993
DADE HEPZYME
K925452 · JBR
Baxter Diagnostics, Inc.
Hematology · 75d
Cleared Jan 05, 1993
DADE(R) CK-MB/MYOGLOBIN IMMUN CONTROL, I,II,III
K926046 · JJY
Baxter Diagnostics, Inc.
Chemistry · 35d
Cleared Dec 15, 1992
BARTELS HERPES SIMPLEX VIRUS 1 IGM EIA
K922334 · LGC
Baxter Diagnostics, Inc.
Microbiology · 216d
Cleared Dec 15, 1992
BARTELS HERPES SIMPLEX VIRUS 2 IGM EIA
K922333 · LGC
Baxter Diagnostics, Inc.
Microbiology · 216d
Cleared Oct 26, 1992
STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED
K924074 · CDD
Baxter Diagnostics, Inc.
Chemistry · 75d
Cleared Oct 19, 1992
STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY
K922073 · DHA
Baxter Diagnostics, Inc.
Chemistry · 168d
Cleared Sep 28, 1992
BARTELS HERPES SIMPLEX VIRUS 2 IGG EIA
K922583 · LGC
Baxter Diagnostics, Inc.
Microbiology · 124d
Cleared Sep 18, 1992
BARTELS HERPES SIMPLEX VIRUS 1 IGG EIA
K922584 · LGC
Baxter Diagnostics, Inc.
Microbiology · 114d
Cleared Sep 17, 1992
STRATUS FOLATE FLUOROMETRIC ENZYME-LINKED ASSAY
K923286 · CGN
Baxter Diagnostics, Inc.
Toxicology · 73d
Cleared Sep 17, 1992
BARTELS RUBELLA IGG EIA
K922586 · LFX
Baxter Diagnostics, Inc.
Microbiology · 113d
Cleared Sep 17, 1992
BARTELS RUBELLA IGM EIA
K922581 · LFX
Baxter Diagnostics, Inc.
Microbiology · 113d