FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMMUCHEM COVALENT-COAT
K Number: K822140
·
Decision Aug 5, 1982
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
27
Applicant Total
18
Review Days
16
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- IMMUCHEM COVALENT-COAT
- K Number
- K822140
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1245
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Immuchem Corp.
- Date Received
- July 20, 1982
- Decision Date
- August 5, 1982
- Product Code
- JKC
- 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 |
|---|---|---|---|
| JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JKC), ordered by most recent decision date.
ACCESS DHEA-S REAGENT ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ELECSYS DHEA-S
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DHEA-S
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DSL DHEA-S-7
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DSL AACTIVE DHEA EIA KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY
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 |
| 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 |
| K820329 | ESTRADIOL KIT BY RIA | Mar 4, 1982 | Substantially Equivalent |