FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMOLAB PROTEIN C CHROMOGENIC ASSAY
K Number: K934210
·
Decision Dec 22, 1994
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
189
Applicant Total
49
Review Days
479
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Basic Information
- Device Name
- HEMOLAB PROTEIN C CHROMOGENIC ASSAY
- K Number
- K934210
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7290
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomerieux Vitek, Inc.
- Date Received
- August 30, 1993
- Decision Date
- December 22, 1994
- Product Code
- GGP
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | FDA class 2 | Hematology |
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|---|---|---|---|
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| K965092 | VIDAS ROTAVIRUS ASSAY | May 5, 1997 | Substantially Equivalent |
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| K955627 | VIDAS CHLAMYDIA BLOCKING ASSAY | Oct 7, 1996 | Substantially Equivalent |
| K962549 | VIDAS CREATINE KINASE MB ASSAY 30-421 | Aug 30, 1996 | Substantially Equivalent |
| K962609 | GRAM NEGATIVE IDENTIFICATION PLUS CARD | Aug 30, 1996 | Substantially Equivalent |
| K952095 | VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) | Mar 12, 1996 | Substantially Equivalent |
| K955647 | VIDAS ESTRADIOL II (E2II) ASSAY | Feb 6, 1996 | Substantially Equivalent |
| K943812 | VIDAS LYME SCREEN II | Jun 13, 1995 | Substantially Equivalent |