FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)
K Number: K963296
·
Decision Dec 16, 1996
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
105
Applicant Total
58
Review Days
117
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Basic Information
- Device Name
- INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)
- K Number
- K963296
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3780
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Incstar Corp.
- Date Received
- August 21, 1996
- Decision Date
- December 16, 1996
- Product Code
- LGD
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | FDA class 2 | Microbiology |
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Other Clearances by Incstar Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K963289 | INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY | May 1, 1997 | Substantially Equivalent |
| K963297 | INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560) | Dec 16, 1996 | Substantially Equivalent |
| K960367 | INCSTAR RUBELLA IGG ELISA ASSAY | Oct 24, 1996 | Substantially Equivalent |
| K960358 | INCSTAR RUBELLA IGG FAST ELISA ASSAY | Oct 24, 1996 | Substantially Equivalent |
| K960434 | INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530 | Oct 17, 1996 | Substantially Equivalent |
| K953567 | INCSTAR 25-HYDROXYVITMIN D 1251 RIA | Sep 25, 1996 | Substantially Equivalent |
| K955362 | INCSTAR HSV I/II IGG FAST ELISA ASSAY | Jul 24, 1996 | Substantially Equivalent |
| K955363 | INCSTAR HSZ I/II IGG ELISA ASSAY | Jul 24, 1996 | Substantially Equivalent |
| K955361 | INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY | Jul 22, 1996 | Substantially Equivalent |
| K955360 | INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAY | Jul 22, 1996 | Substantially Equivalent |