FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA
K Number: K873186
·
Decision Sep 29, 1987
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
142
Applicant Total
25
Review Days
48
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Basic Information
- Device Name
- LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA
- K Number
- K873186
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1485
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Serono Diagnostics, Inc.
- Date Received
- August 12, 1987
- Decision Date
- September 29, 1987
- Product Code
- CEP
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| CEP | Radioimmunoassay, Luteinizing Hormone | FDA class 1 | Clinical Chemistry |
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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 |
| 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 |
| K873033 | HCG SEROZYME IMMUNOENZYM ASSAY KIT/MAG SOLID PHASE | Sep 14, 1987 | Substantially Equivalent |