FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FACT* HOME PREGNANCY TEST
K Number: K810581
·
Decision Mar 17, 1981
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
95
Applicant Total
9
Review Days
14
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Basic Information
- Device Name
- FACT* HOME PREGNANCY TEST
- K Number
- K810581
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Ortho Pharmaceutical Corp.
- Date Received
- March 3, 1981
- Decision Date
- March 17, 1981
- Product Code
- JHJ
- 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 |
|---|---|---|---|
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | FDA class 2 | Clinical Chemistry |
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Other Clearances by Ortho Pharmaceutical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K955648 | K-Y PERSONAL LUBRICANT | Jun 21, 1996 | Substantially Equivalent |
| K934516 | ADVANCE PREGNANCY TEST MODIFICATION | Feb 24, 1994 | Substantially Equivalent |
| K914990 | ADVANCE(R) PREGNANCY TEST | Dec 23, 1991 | Substantially Equivalent |
| K893488 | PULSATILE PUMP FOR GONADORELIN ACETATE | Oct 31, 1989 | Substantially Equivalent |
| K881151 | MICROSCRAPE | Apr 6, 1988 | Substantially Equivalent |
| K800754 | NICKERSON'S MED. SELECTIVE CULTURE MEDIU | Apr 29, 1980 | Substantially Equivalent |
| K792634 | CONCEPTROL/THIN PROPHYLACTICS | Jan 16, 1980 | Substantially Equivalent |
| K790087 | LUBRICANT, OTRHO PERSONAL | Feb 1, 1979 | Substantially Equivalent |