FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IN VITRO THEOPHYLLINE RIA TEST
K Number: K772017
·
Decision Mar 27, 1978
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
70
Applicant Total
27
Review Days
152
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Basic Information
- Device Name
- IN VITRO THEOPHYLLINE RIA TEST
- K Number
- K772017
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3880
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Clinical Assays, Inc.
- Date Received
- October 26, 1977
- Decision Date
- March 27, 1978
- Product Code
- KLS
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| KLS | Enzyme Immunoassay, Theophylline | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KLS), ordered by most recent decision date.
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FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Clinical Assays, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K832711 | VITAMIN B12 FOLATE CA-1515-125 | Oct 4, 1983 | Substantially Equivalent |
| K832712 | FOLATE RADIOASSAY KIT CA-1562-125 | Oct 4, 1983 | Substantially Equivalent |
| K832710 | VITAMIN B12 RADIOASSAY KIT CA-1534 | Oct 4, 1983 | Substantially Equivalent |
| K823476 | GAMMADAB LH RADIO-KIT #CA-1508 | Dec 28, 1982 | Substantially Equivalent |
| K823313 | IN VITRO GAMMACOAT B-HCG RADIO. TEST | Dec 22, 1982 | Substantially Equivalent |
| K821611 | GAMMADAB [125] FSH RADIOIMMUNAY KIT | Jun 24, 1982 | Substantially Equivalent |
| K821092 | GAMMADAB[125]EGE RADIOIMMUNOASSAY IT | Jun 22, 1982 | Substantially Equivalent |
| K812227 | GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY | Sep 24, 1981 | Substantially Equivalent |
| K810722 | GASTRIN RADIOIMMUNOASSAY TEST | May 27, 1981 | Substantially Equivalent |
| K810967 | IN-VITRO TBG RADIOIMMUNOASSAY TEST | Apr 23, 1981 | Substantially Equivalent |