FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPUS FT4 TEST SYSTEM
K Number: K940507
·
Decision Jul 28, 1994
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
91
Applicant Total
35
Review Days
176
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Basic Information
- Device Name
- OPUS FT4 TEST SYSTEM
- K Number
- K940507
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1695
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pb Diagnostic Systems, Inc.
- Date Received
- February 2, 1994
- Decision Date
- July 28, 1994
- Product Code
- CEC
- 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 |
|---|---|---|---|
| CEC | Radioimmunoassay, Free Thyroxine | FDA class 2 | Clinical Chemistry |
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Other Clearances by Pb Diagnostic Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K934762 | OPUS PROCAINAMIDE TEST SYSTEM | Jul 20, 1994 | Substantially Equivalent |
| K933389 | OPUS CMV-G | Jun 28, 1994 | Substantially Equivalent |
| K934137 | OPUS(R) SEROLOGY CONTROLS, MODIFICATION | Mar 7, 1994 | Substantially Equivalent |
| K935229 | OPUS DIGITOXIN | Dec 22, 1993 | Substantially Equivalent |
| K934705 | OPUS NAPA | Nov 22, 1993 | Substantially Equivalent |
| K933675 | OPUS TOTAL CK | Sep 8, 1993 | Substantially Equivalent |
| K933066 | OPUS ESTRADIOL | Sep 8, 1993 | Substantially Equivalent |
| K932279 | OPUS(R) TOTAL B-HCG TEST SYSTEM | Jul 8, 1993 | Substantially Equivalent |
| K926131 | OPUS MAGNUM ANALYZER | Jun 7, 1993 | Substantially Equivalent |
| K924957 | OPUS(R) VANCOMYCIN | Dec 11, 1992 | Substantially Equivalent |