FDA 510(k)
Substantially Equivalent
🇺🇸 United States
T3 UPTAKE DIAG. KIT
K Number: K771585
·
Decision Sep 13, 1977
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
16
Review Days
26
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Basic Information
- Device Name
- T3 UPTAKE DIAG. KIT
- K Number
- K771585
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Antibodies, Inc.
- Date Received
- August 18, 1977
- Decision Date
- September 13, 1977
- Advisory Committee
- Unknown
- Review Advisory Committee
- CH
- Third Party
- N
Other Clearances by Antibodies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K890774 | GIARDEIA(TM) | Apr 4, 1989 | Substantially Equivalent |
| K843590 | DETECT-A-STREP | Oct 30, 1984 | Substantially Equivalent |
| K822892 | CORTISOL RIA KIT | Nov 1, 1982 | Substantially Equivalent |
| K812749 | ULTRA-DIG | Oct 19, 1981 | Substantially Equivalent |
| K812314 | CRITHIDNA ANTI-DNA TEST KIT | Sep 1, 1981 | Substantially Equivalent |
| K802877 | AMIKACIN RIA KIT | Dec 19, 1980 | Substantially Equivalent |
| K800743 | TOBRAMYCIN RIA KIT | Apr 16, 1980 | Substantially Equivalent |
| K791217 | TSH RIA KIT | Sep 4, 1979 | Substantially Equivalent |
| K781655 | NEPHELRATE ANTISERUMS 1GA | Nov 8, 1978 | Substantially Equivalent |
| K781654 | NEPHELRATE ANTIPERUMS LGM | Nov 8, 1978 | Substantially Equivalent |