FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPQ PAL CONTROL LEVEL II
K Number: K934966
·
Decision Jan 11, 1994
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
3
Applicant Total
58
Review Days
88
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Basic Information
- Device Name
- SPQ PAL CONTROL LEVEL II
- K Number
- K934966
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.5060
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Incstar Corp.
- Date Received
- October 15, 1993
- Decision Date
- January 11, 1994
- Product Code
- DDS
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| DDS | Prealbumin, Fitc, Antigen, Antiserum, Control | FDA class 1 | Immunology |
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|---|---|---|---|
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| 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 |