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

58 results for "Incstar Corp."
1–24 of 58
Search insights Median review: 88d Cleared: 100% Top manufacturer: Incstar Corp. Lead specialty: Immunology
Cleared May 01, 1997
INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY
K963289 · LGD
Incstar Corp.
Microbiology · 253d
Cleared Dec 16, 1996
INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)
K963297 · LGD
Incstar Corp.
Microbiology · 117d
Cleared Dec 16, 1996
INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)
K963296 · LGD
Incstar Corp.
Microbiology · 117d
Cleared Oct 24, 1996
INCSTAR RUBELLA IGG ELISA ASSAY
K960367 · LFX
Incstar Corp.
Microbiology · 273d
Cleared Oct 24, 1996
INCSTAR RUBELLA IGG FAST ELISA ASSAY
K960358 · LFX
Incstar Corp.
Microbiology · 273d
Cleared Oct 17, 1996
INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530
K960434 · LFZ
Incstar Corp.
Microbiology · 260d
Cleared Sep 25, 1996
INCSTAR 25-HYDROXYVITMIN D 1251 RIA
K953567 · MRG
Incstar Corp.
Chemistry · 422d
Cleared Jul 24, 1996
INCSTAR HSZ I/II IGG ELISA ASSAY
K955363 · IGC
Incstar Corp.
Microbiology · 245d
Cleared Jul 24, 1996
INCSTAR HSV I/II IGG FAST ELISA ASSAY
K955362 · IGC
Incstar Corp.
Microbiology · 245d
Cleared Jul 22, 1996
INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY
K955361 · LFZ
Incstar Corp.
Microbiology · 243d
Cleared Jul 22, 1996
INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAY
K955360 · LFZ
Incstar Corp.
Microbiology · 243d
Cleared Oct 13, 1995
COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE)
K951639 · DAE
Incstar Corp.
Immunology · 186d
Cleared Jun 09, 1995
INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT
K946158 · LLM
Incstar Corp.
Microbiology · 183d
Cleared Jun 07, 1995
INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) IGG ELISA KIT
K946159 · LSE
Incstar Corp.
Microbiology · 181d
Cleared Jun 07, 1995
INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) LGM ELISA KIT
K946157 · LSE
Incstar Corp.
Microbiology · 181d
Cleared Sep 07, 1994
CLINICAL ASSAYS GAMMACOAT [125] ESTRADIOL RADIOIMMUNOASSAY KIT
K941168 · CHP
Incstar Corp.
Chemistry · 177d
Cleared Aug 02, 1994
INCSTAR ACTH IRMA
K940271 · CKG
Incstar Corp.
Chemistry · 193d
Cleared Jan 11, 1994
SPQ CRP CONTROL LEVEL II
K935075 · DCN
Incstar Corp.
Immunology · 78d
Cleared Jan 11, 1994
SPQ PAL CONTROL LEVEL II
K934966 · DDS
Incstar Corp.
Immunology · 88d
Cleared Nov 26, 1993
SPQ MALB CONTROL LEVEL II
K934521 · JJX
Incstar Corp.
Chemistry · 70d
Cleared Sep 14, 1992
EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA
K921628 · LSE
Incstar Corp.
Microbiology · 161d
Cleared Aug 11, 1992
CMV-VUE(TM) CMV ANTIGEN DETECTION KIT
K921616 · LIN
Incstar Corp.
Microbiology · 127d
Cleared May 14, 1992
N-TACT(R) PTH SP KIT
K921629 · CEW
Incstar Corp.
Chemistry · 38d
Cleared Jan 28, 1992
CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT
K915235 · CDX
Incstar Corp.
Chemistry · 67d