FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL
K Number: K883726
·
Decision Dec 15, 1988
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
241
Applicant Total
18
Review Days
106
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Basic Information
- Device Name
- THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL
- K Number
- K883726
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1690
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Immuchem Corp.
- Date Received
- August 31, 1988
- Decision Date
- December 15, 1988
- Product Code
- JLW
- 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 |
|---|---|---|---|
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | FDA class 2 | Clinical Chemistry |
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Other Clearances by Immuchem Corp.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K854094 | IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS | Feb 28, 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 |