FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS
K Number: K854094
·
Decision Feb 28, 1986
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
56
Applicant Total
18
Review Days
144
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Basic Information
- Device Name
- IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS
- K Number
- K854094
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1620
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Immuchem Corp.
- Date Received
- October 7, 1985
- Decision Date
- February 28, 1986
- 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.
LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA
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PROGESTERONE ELISA
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VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)
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OPUS PROGESTERONE
FDA 510(k)
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ELECSYS PROGESTERONE ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VIDAS PROESTERONE (PRG) (30 409)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Immuchem Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K883726 | THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL | Dec 15, 1988 | Substantially Equivalent |
| K871317 | FOLLICLE STIMULATING HORMONE (HFSH) | May 20, 1987 | Substantially Equivalent |
| K871542 | HPROLACTIN KIT | May 14, 1987 | Substantially Equivalent |
| K865071 | THYROID STIMULATING HORMONE (TSH IRMA) RIA KIT | Mar 13, 1987 | Substantially Equivalent |
| K864144 | LUTEINIZING HORMONE (LH-IRMA) RIA KIT | Nov 24, 1986 | Substantially Equivalent |
| K860559 | ANDROSTENEDIONE 125I KIT BY RIA | Mar 14, 1986 | Substantially Equivalent |
| K830962 | IMMUCHEM COVALENT-COAT RIA KIT | May 4, 1983 | Substantially Equivalent |
| K822509 | COVALENT COAT RIA KIT | Sep 28, 1982 | Substantially Equivalent |
| K822140 | IMMUCHEM COVALENT-COAT | Aug 5, 1982 | Substantially Equivalent |
| K820329 | ESTRADIOL KIT BY RIA | Mar 4, 1982 | Substantially Equivalent |