FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SR1 DHEA-S ENZYME IMMUNOASSAY
K Number: K942051
·
Decision Jul 13, 1994
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
27
Applicant Total
25
Review Days
76
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Basic Information
- Device Name
- SR1 DHEA-S ENZYME IMMUNOASSAY
- K Number
- K942051
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1245
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Serono Diagnostics, Inc.
- Date Received
- April 28, 1994
- Decision Date
- July 13, 1994
- Product Code
- JKC
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | 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 |
| 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 |
| K873033 | HCG SEROZYME IMMUNOENZYM ASSAY KIT/MAG SOLID PHASE | Sep 14, 1987 | Substantially Equivalent |