FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NORMAL AND ABNORMAL CONTROL SERA
K Number: K895943
·
Decision Dec 27, 1989
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
672
Applicant Total
82
Review Days
77
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Basic Information
- Device Name
- NORMAL AND ABNORMAL CONTROL SERA
- K Number
- K895943
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Sclavo, Inc.
- Date Received
- October 11, 1989
- Decision Date
- December 27, 1989
- Product Code
- JJY
- 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | FDA class 1 | Clinical Chemistry |
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Other Clearances by Sclavo, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K914420 | ELISA RUBELLA IGM | Dec 27, 1991 | Substantially Equivalent |
| K895822 | TOTAL BILIRUBIN L.F. | Nov 14, 1989 | Substantially Equivalent |
| K895847 | CREATININE 340 (ENZYMATIC) | Oct 30, 1989 | Substantially Equivalent |
| K880049 | CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE | Jan 27, 1989 | Substantially Equivalent |
| K880199 | CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE | Jan 27, 1989 | Substantially Equivalent |
| K873496 | ATYPICAL CHOLINESTERASE | Jan 27, 1989 | Substantially Equivalent |
| K884035 | SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER | Dec 29, 1988 | Substantially Equivalent |
| K884649 | TOTAL IRON BINDING CAPACITY TEST | Dec 14, 1988 | Substantially Equivalent |