FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROTHROMBIN TIME TEST
K Number: K872537
·
Decision Aug 27, 1987
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
126
Applicant Total
82
Review Days
63
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Basic Information
- Device Name
- PROTHROMBIN TIME TEST
- K Number
- K872537
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7750
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Sclavo, Inc.
- Date Received
- June 25, 1987
- Decision Date
- August 27, 1987
- Product Code
- GJS
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| GJS | Test, Time, Prothrombin | FDA class 2 | Hematology |
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|---|---|---|---|
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| 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 |