FDA 510(k)
Substantially Equivalent
🇺🇸 United States
REAGENT, PARTIAL THROMBOPLASTIN
K Number: K760499
·
Decision Oct 29, 1976
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
44
Review Days
67
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Basic Information
- Device Name
- REAGENT, PARTIAL THROMBOPLASTIN
- K Number
- K760499
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Hyland Therapeutic Div., Travenol Laboratories
- Date Received
- August 23, 1976
- Decision Date
- October 29, 1976
- Advisory Committee
- Unknown
- Review Advisory Committee
- CV
- Third Party
- N
Other Clearances by Hyland Therapeutic Div., Travenol Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K820835 | ALUMINA SILICA-ACTIVATED PARTIAL THROM | Apr 26, 1982 | Substantially Equivalent |
| K820192 | HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM | Mar 11, 1982 | Substantially Equivalent |
| K812220 | NEPHELOMETRIC SOLID TURBIDITY STANDARD | Aug 18, 1981 | Substantially Equivalent |
| K810078 | Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S | Feb 2, 1981 | Substantially Equivalent |
| K810077 | OMEGA THERAPEUTIC DRUG MONIT. CONTROL S. | Jan 28, 1981 | Substantially Equivalent |
| K802610 | ALERT A,HDL-APOLIPOROTEIN A, TEST KIT | Jan 5, 1981 | Substantially Equivalent |
| K791113 | LOW IONIC STRENGTH SOLUTION (LISS) | Jun 28, 1979 | Substantially Equivalent |
| K790249 | TEST CELLS | May 16, 1979 | Substantially Equivalent |
| K781225 | GLOBULIN TEST, HUMAN THYROXINE BINDING | Aug 31, 1978 | Substantially Equivalent |
| K780962 | AUTOMATED ENZYME | Jul 27, 1978 | Substantially Equivalent |