FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORTHO TSH RIA KIT
K Number: K791301
·
Decision Sep 24, 1979
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
241
Applicant Total
24
Review Days
70
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Basic Information
- Device Name
- ORTHO TSH RIA KIT
- K Number
- K791301
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1690
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Ortho Diagnostics, Inc.
- Date Received
- July 16, 1979
- Decision Date
- September 24, 1979
- Product Code
- JLW
- 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 |
|---|---|---|---|
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | FDA class 2 | Clinical Chemistry |
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Other Clearances by Ortho Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K802404 | ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE | Oct 23, 1980 | Substantially Equivalent |
| K801507 | ANTIGEN CONTROL CELLS | Aug 20, 1980 | Substantially Equivalent |
| K800357 | BI-LEVEL ASSAYED CARD. DRUG CONT., I,II | Apr 16, 1980 | Substantially Equivalent |
| K800310 | ORTHO ANTISERA CONTROL | Mar 5, 1980 | Substantially Equivalent |
| K791791 | ORTHO ANTIBODY ENHANCEMENT SOLUTION | Oct 11, 1979 | Substantially Equivalent |
| K790813 | MULTECON BLOOD GAS CONTROL | Jun 28, 1979 | Substantially Equivalent |
| K782063 | PREGNANCY, SENSIDEX TUBE TEST | Apr 4, 1979 | Substantially Equivalent |
| K782166 | SLIDE TEST FOR PREGNANCY, GRAVINDEX 90 | Apr 4, 1979 | Substantially Equivalent |
| K781638 | RUBINDEX*DIRECT SYSTEM | Dec 20, 1978 | Substantially Equivalent |
| K781860 | ASSAY, CHROMOGENIC ANTITHROMBIN III | Dec 4, 1978 | Substantially Equivalent |