FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OPUS IMMUNOASSAY SYSTEM
K Number: K894159
·
Decision Aug 3, 1989
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
37
Applicant Total
35
Review Days
50
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Basic Information
- Device Name
- OPUS IMMUNOASSAY SYSTEM
- K Number
- K894159
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2560
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Pb Diagnostic Systems, Inc.
- Date Received
- June 14, 1989
- Decision Date
- August 3, 1989
- Product Code
- KHO
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| KHO | Fluorometer, For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Pb Diagnostic Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K940507 | OPUS FT4 TEST SYSTEM | Jul 28, 1994 | Substantially Equivalent |
| 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 |