FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SLIDE PREGNANCY TEST
K Number: K842110
·
Decision Jul 12, 1984
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
95
Applicant Total
11
Review Days
44
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Basic Information
- Device Name
- SLIDE PREGNANCY TEST
- K Number
- K842110
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Immunostics Co., Inc.
- Date Received
- May 29, 1984
- Decision Date
- July 12, 1984
- 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 |
Similar 510(k) Clearances
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Other Clearances by Immunostics Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K926569 | IMMUNO RA UNDILUTED | Apr 6, 1993 | Substantially Equivalent |
| K902360 | HEMA-SCREEN | Jul 27, 1990 | Substantially Equivalent |
| K894780 | IMMUNO/ASO | Oct 16, 1989 | Substantially Equivalent |
| K883685 | IMMUNO/FEBRILE ANTIGENS | Sep 28, 1988 | Substantially Equivalent |
| K872910 | IMMUNO/SLE | Aug 12, 1987 | Substantially Equivalent |
| K863741 | IMMUNO-CEPT D (BETA-MONOCLONAL) | Nov 13, 1986 | Substantially Equivalent |
| K854619 | DETECTACULT | Mar 3, 1986 | Substantially Equivalent |
| K853105 | IMMUNO-IM | Sep 3, 1985 | Substantially Equivalent |
| K834390 | IMMUNO-CRP | Feb 3, 1984 | Substantially Equivalent |
| K834391 | IMMUNO-RA | Feb 3, 1984 | Substantially Equivalent |