FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
OVEIA (TM) DUAL ANALYTE
K Number: K872843
·
Decision Feb 2, 1988
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
20
Review Days
197
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Basic Information
- Device Name
- OVEIA (TM) DUAL ANALYTE
- K Number
- K872843
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1605
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Boots-Celltech Diagnostics, Inc.
- Date Received
- July 20, 1987
- Decision Date
- February 2, 1988
- Product Code
- JLP
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JLP | Spectrophotometric Method, Pregnanediol | FDA class 1 | Clinical Chemistry |
Other Clearances by Boots-Celltech Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K871877 | IDEIA HERPES SIMPLEX VIRUS TEST | Nov 17, 1989 | Substantially Equivalent |
| K880799 | MODIFIED IDEIA CHLAMYDIA TEST | Dec 8, 1988 | Substantially Equivalent |
| K880758 | SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY | Apr 18, 1988 | Substantially Equivalent |
| K874875 | CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA) | Mar 24, 1988 | Substantially Equivalent |
| K872958 | IMAGEN INFLUENZA VIRUS A AND B TESTMI | Feb 24, 1988 | Substantially Equivalent |
| K873625 | CHEMELIA ENZYME IMMUNOASSAY FOR (TSH) | Oct 20, 1987 | Substantially Equivalent |
| K872056 | MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST | Jun 15, 1987 | Substantially Equivalent |
| K870602 | IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST | May 8, 1987 | Substantially Equivalent |
| K864998 | IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT | Apr 20, 1987 | Substantially Equivalent |
| K864539 | MODIFIED IMAGEN(TM) CHLAMYDIA TEST | Mar 12, 1987 | Substantially Equivalent |