FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAY
K Number: K820616
·
Decision Mar 26, 1982
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
15
Applicant Total
32
Review Days
18
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Basic Information
- Device Name
- ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAY
- K Number
- K820616
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1085
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- E. R. Squibb & Sons, Inc.
- Date Received
- March 8, 1982
- Decision Date
- March 26, 1982
- Product Code
- CIB
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| CIB | Radioimmunoassay, Angiotensin I And Renin | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CIB), ordered by most recent decision date.
IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CISBIO RENIN RIA TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACTIVE RENIN IRMA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACTIVE RENIN IRMA MODEL NUMBER DSL-25100
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by E. R. Squibb & Sons, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K821494 | RIA STAT 16 | Jun 3, 1982 | Substantially Equivalent |
| K820340 | T3 UPTAKE-SQUIBB DIAGNOSTIC KIT | Mar 4, 1982 | Substantially Equivalent |
| K820341 | CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT | Mar 4, 1982 | Substantially Equivalent |
| K811240 | SUR-FIT LOOP OSTOMY O.R. SET | Jun 16, 1981 | Substantially Equivalent |
| K811239 | SUR-FIT DISPOSABLE CONVEX INSERT | Jun 9, 1981 | Substantially Equivalent |
| K811160 | SUR-FIT IRRIGATION SLEEVE | Jun 2, 1981 | Substantially Equivalent |
| K811163 | SUR-FIT DISPOSABLE FANGE CAP | May 21, 1981 | Substantially Equivalent |
| K810966 | DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT | Apr 21, 1981 | Substantially Equivalent |
| K810211 | T3 RIA KIT | Feb 10, 1981 | Substantially Equivalent |
| K803100 | STOMAHESIVE PASTE PROTECTIVE SKIN BARR | Jan 8, 1981 | Substantially Equivalent |