FDA 510(k)
Substantially Equivalent
🇺🇸 United States
GASTRIN RADIOIMMUNOASSAY TEST KIT
K Number: K842965
·
Decision Oct 11, 1984
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
25
Review Days
76
Basic Information
- Device Name
- GASTRIN RADIOIMMUNOASSAY TEST KIT
- K Number
- K842965
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- SERONO DIAGNOSTICS, INC.
- Date Received
- July 27, 1984
- Decision Date
- October 11, 1984
- Advisory Committee
- Unknown
- Review Advisory Committee
- CH
- Third Party
- N
Other Clearances by SERONO DIAGNOSTICS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K953598 | SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS | Mar 11, 1996 | Substantially Equivalent |
| K942051 | SR1 DHEA-S ENZYME IMMUNOASSAY | Jul 13, 1994 | Substantially Equivalent |
| K883085 | T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS | Sep 9, 1988 | Substantially Equivalent |
| K882340 | LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA | Aug 8, 1988 | Substantially Equivalent |
| K880388 | T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE | Mar 3, 1988 | Substantially Equivalent |
| K874866 | T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE | Feb 11, 1988 | Substantially Equivalent |
| K873431 | PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH | Oct 20, 1987 | Substantially Equivalent |
| K873186 | LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA | Sep 29, 1987 | Substantially Equivalent |
| K873400 | PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA | Sep 25, 1987 | Substantially Equivalent |
| K872862 | PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS | Sep 18, 1987 | Substantially Equivalent |