FDA 510(k)
FDA class 1
Substantially Equivalent
🇫🇷 France
PROGESTERONE RADIOIMMUNOASSAY KIT
K Number: K931228
·
Decision Oct 22, 1993
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
56
Applicant Total
37
Review Days
226
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Basic Information
- Device Name
- PROGESTERONE RADIOIMMUNOASSAY KIT
- K Number
- K931228
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1620
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Immunotech Corp.
- Date Received
- March 10, 1993
- Decision Date
- October 22, 1993
- Product Code
- JLS
- 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 |
|---|---|---|---|
| JLS | Radioimmunoassay, Progesterone | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JLS), ordered by most recent decision date.
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Other Clearances by Immunotech Corp.
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|---|---|---|---|
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| K950626 | OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES | May 5, 1995 | Substantially Equivalent |
| K911634 | MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST | Jun 24, 1991 | Substantially Equivalent |
| K911153 | MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT | Jun 18, 1991 | Substantially Equivalent |
| K910411 | MICROZYME TSH ENZYME IMMUNOASSAY KIT | Apr 3, 1991 | Substantially Equivalent |
| K905777 | MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT | Jan 30, 1991 | Substantially Equivalent |
| K903993 | MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT | Dec 20, 1990 | Substantially Equivalent |
| K904820 | MICROZYME T3 ENZYME IMMUNOASSAY KIT | Dec 18, 1990 | Substantially Equivalent |
| K904635 | MICROZYME THC ENZYME IMMUNOASSAY TEST KIT | Nov 1, 1990 | Substantially Equivalent |