FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECTRIC SELF STERILIZATION INOCUL. LOOP
K Number: K813523
·
Decision Dec 31, 1981
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
0
Applicant Total
6
Review Days
15
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Basic Information
- Device Name
- ELECTRIC SELF STERILIZATION INOCUL. LOOP
- K Number
- K813523
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1235
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Techhnilab Instruments, Inc.
- Date Received
- December 16, 1981
- Decision Date
- December 31, 1981
- Product Code
- LTB
- 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 |
|---|---|---|---|
| LTB | Cyclosporine Radioimmunoassay | FDA class 2 | Clinical Chemistry |
Other Clearances by Techhnilab Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K780543 | THERMAJUST CIRCU-TEMP | May 26, 1978 | Substantially Equivalent |
| K780544 | DISC-PAK ROTATOR | Apr 24, 1978 | Substantially Equivalent |
| K771434 | MULTI-CAVITY EQUILIBRIUM CELL | Aug 22, 1977 | Substantially Equivalent |
| K770169 | BEESON AUTOMADDAK FEEDER | Jan 28, 1977 | Substantially Equivalent |
| K770170 | MADDATHERM PARAFFIN BATH | Jan 28, 1977 | Substantially Equivalent |