FDA 510(k)
Substantially Equivalent
🇺🇸 United States
IMMUNOFLUORESCENCE TEST KIT
K Number: K781143
·
Decision Aug 14, 1978
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
8
Review Days
35
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- IMMUNOFLUORESCENCE TEST KIT
- K Number
- K781143
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Microbiological Assoc.
- Date Received
- July 10, 1978
- Decision Date
- August 14, 1978
- Advisory Committee
- Unknown
- Review Advisory Committee
- IM
- Third Party
- N
Other Clearances by Microbiological Assoc.
| K Number | Device Name | ||
|---|---|---|---|
| K792133 | RUBELISA TEST KIT | Jan 11, 1980 | Substantially Equivalent |
| K791397 | HERPES EIA TEST KIT | Sep 24, 1979 | Substantially Equivalent |
| K781549 | TOXELISA TEST KIT | Dec 7, 1978 | Substantially Equivalent |
| K780996 | RUBELISA TEST KIT | Nov 22, 1978 | Substantially Equivalent |
| K781392 | CYTOMEGILISH TEST KIT | Oct 24, 1978 | Substantially Equivalent |
| K770764 | TISSUE CULTURE MEDIA W/HEPES BUFFER | Jul 21, 1977 | Substantially Equivalent |
| K770687 | MEASLESVIRUS FLOURE. CONJUGATED ANTISERU | Jun 14, 1977 | Substantially Equivalent |