Company ยท US
Incstar Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1987 to 1997. Name variants (Inc, Corp, punctuation) are merged.
58510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 25 |
| CEW | Radioimmunoassay, Parathyroid Hormone | 3 |
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 3 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 3 |
| LSE | Epstein-Barr Virus, Other | 3 |
| GGT | Assay, Erythropoietin | 2 |
| IGC | Formalin-Saline | 2 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 |
| CHP | Radioimmunoassay, Estradiol | 1 |
| CKG | Radioimmunoassay, Acth | 1 |
| DAE | Complement C9, Antigen, Antiserum, Control | 1 |
| DCN | System, Test, C-Reactive Protein | 1 |
| DDS | Prealbumin, Fitc, Antigen, Antiserum, Control | 1 |
| DGC | Ige, Antigen, Antiserum, Control | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 |
| JZG | System, Test, Beta-2-Microglobulin Immunological | 1 |
| JZW | Nephelometer | 1 |
| KQJ | System, Fibrinogen Determination | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 1, 1997 | K963289 | INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY Incstar Corp. | LGD |
| Dec 16, 1996 | K963297 | INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560) Incstar Corp. | LGD |
| Dec 16, 1996 | K963296 | INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565) Incstar Corp. | LGD |
| Oct 24, 1996 | K960367 | INCSTAR RUBELLA IGG ELISA ASSAY Incstar Corp. | LFX |
| Oct 24, 1996 | K960358 | INCSTAR RUBELLA IGG FAST ELISA ASSAY Incstar Corp. | LFX |
| Oct 17, 1996 | K960434 | INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530 Incstar Corp. | LFZ |
| Sep 25, 1996 | K953567 | INCSTAR 25-HYDROXYVITMIN D 1251 RIA Incstar Corp. | MRG |
| Jul 24, 1996 | K955363 | INCSTAR HSZ I/II IGG ELISA ASSAY Incstar Corp. | IGC |
| Jul 24, 1996 | K955362 | INCSTAR HSV I/II IGG FAST ELISA ASSAY Incstar Corp. | IGC |
| Jul 22, 1996 | K955361 | INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY Incstar Corp. | LFZ |
| Jul 22, 1996 | K955360 | INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAY Incstar Corp. | LFZ |
| Oct 13, 1995 | K951639 | COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE) Incstar Corp. | DAE |
| Jun 9, 1995 | K946158 | INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT Incstar Corp. | LLM |
| Jun 7, 1995 | K946159 | INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) IGG ELISA KIT Incstar Corp. | LSE |
| Jun 7, 1995 | K946157 | INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) LGM ELISA KIT Incstar Corp. | LSE |
| Sep 7, 1994 | K941168 | CLINICAL ASSAYS GAMMACOAT [125] ESTRADIOL RADIOIMMUNOASSAY KIT Incstar Corp. | CHP |
| Aug 2, 1994 | K940271 | INCSTAR ACTH IRMA Incstar Corp. | CKG |
| Jan 11, 1994 | K935075 | SPQ CRP CONTROL LEVEL II Incstar Corp. | DCN |
| Jan 11, 1994 | K934966 | SPQ PAL CONTROL LEVEL II Incstar Corp. | DDS |
| Nov 26, 1993 | K934521 | SPQ MALB CONTROL LEVEL II Incstar Corp. | JJX |
| Sep 14, 1992 | K921628 | EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA Incstar Corp. | LSE |
| Aug 11, 1992 | K921616 | CMV-VUE(TM) CMV ANTIGEN DETECTION KIT Incstar Corp. | LIN |
| May 14, 1992 | K921629 | N-TACT(R) PTH SP KIT Incstar Corp. | CEW |
| Jan 28, 1992 | K915235 | CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT Incstar Corp. | CDX |
| Jan 27, 1992 | K915570 | GAMMA COAT ASSAY TESTOSTERONE RADIOIMMUNOASSAY KIT Incstar Corp. | CDZ |
| Aug 22, 1990 | K902639 | EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA) Incstar Corp. | GGT |
| Jul 16, 1990 | K901711 | PTH-MM II 125I RADIOIMMUNOASSAY (RIA) Incstar Corp. | CEW |
| May 16, 1990 | K900939 | SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.) Incstar Corp. | KQJ |
| Nov 21, 1989 | K893393 | EPO-TRAC BY RADIOIMMUNOASSAY (RIA) Incstar Corp. | GGT |
| Oct 17, 1989 | K895496 | BETA2 M-TRAC BY ENZYME BEAD-BASED IMMUNOASSAY EIA Incstar Corp. | JZG |
| Jun 14, 1988 | K875110 | HOUSE DUST; HOLLISTER-STIER (H/S) ALLERGEN DISC Incstar Corp. | DHB |
| May 11, 1988 | K880221 | INCSTAR'S PIGWEED ALLERGEN DISC Incstar Corp. | DHB |
| May 11, 1988 | K880168 | INCSTAR'S BIRCH ALLERGEN DISC Incstar Corp. | DHB |
| May 11, 1988 | K874883 | WALNUT ALLERGEN DISC Incstar Corp. | DHB |
| May 11, 1988 | K874540 | MARSH ELDER ALLERGEN DISC Incstar Corp. | DHB |
| Apr 21, 1988 | K880567 | WHITE ASH ALLERGEN DISC Incstar Corp. | DHB |
| Apr 21, 1988 | K880415 | MESQUITE ALLERGEN DISC Incstar Corp. | DHB |
| Apr 21, 1988 | K880187 | INCSTAR'S DANDELION ALLERGEN DISC Incstar Corp. | DHB |
| Apr 21, 1988 | K875163 | GOLDENROD ALLERGEN DISC Incstar Corp. | DHB |
| Feb 17, 1988 | K875274 | TOTAL IGE IMMUNO RESPONSE TEST (IRT(R)) Incstar Corp. | DHB |
| Feb 17, 1988 | K874541 | RRT TOTAL IGE TEST KIT Incstar Corp. | DGC |
| Nov 25, 1987 | K874440 | LIVE OAK ALLERGEN DISC Incstar Corp. | DHB |
| Nov 23, 1987 | K874299 | N-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA) Incstar Corp. | CEW |
| Nov 4, 1987 | K874150 | JOHNSON GRASS ALLERGEN DISC Incstar Corp. | DHB |
| Nov 4, 1987 | K874149 | FALSE RAGWEED ALLERGEN DISC Incstar Corp. | DHB |
| Nov 4, 1987 | K873969 | GIANT RAGWEED ALLERGEN DISC Incstar Corp. | DHB |
| Oct 20, 1987 | K873814 | IGE IMMUNO RESPONSE TEST (IRT) COMP. FOR MOD. RAST Incstar Corp. | DHB |
| Oct 20, 1987 | K873770 | BERMUDA GRASS ALLERGEN DISC Incstar Corp. | DHB |
| Oct 8, 1987 | K873648 | BAHIA ALLERGEN DISC Incstar Corp. | DHB |
| Oct 7, 1987 | K873676 | IGE IMMUNO RESPONSE TEST (IRT) CALIBRATOR UNIT Incstar Corp. | DHB |
Newest 50 of 58.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||