FDA 510(k)
Substantially Equivalent
🇺🇸 United States
TEST, IN-VITRO DIAGNOSTIC
K Number: K760089
·
Decision Jul 20, 1976
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
49
Review Days
29
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
- TEST, IN-VITRO DIAGNOSTIC
- K Number
- K760089
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Hoffmann-La Roche, Inc.
- Date Received
- June 21, 1976
- Decision Date
- July 20, 1976
- Advisory Committee
- Unknown
- Review Advisory Committee
- IM
- Third Party
- N
Other Clearances by Hoffmann-La Roche, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K850727 | BHCG-ROCHE EIA | Jun 25, 1985 | Substantially Equivalent |
| K831694 | RENAK | Jul 19, 1983 | Substantially Equivalent |
| K830481 | ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE | Mar 24, 1983 | Substantially Equivalent |
| K830480 | ABUSCREEN RADIOIMMUNOASSAY-COCAINE META | Mar 24, 1983 | Substantially Equivalent |
| K830461 | ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE | Mar 24, 1983 | Substantially Equivalent |
| K830460 | ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE | Mar 24, 1983 | Substantially Equivalent |
| K830482 | ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE | Mar 24, 1983 | Substantially Equivalent |
| K830462 | ABUSCREEN RADIOUMMUNOASSAY--URINE | Mar 24, 1983 | Substantially Equivalent |
| K830479 | ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE | Mar 10, 1983 | Substantially Equivalent |
| K823579 | COBAS REAGENT FOR TOTAL PROTEIN | Jan 7, 1983 | Substantially Equivalent |