FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SHARIA-LH RIA KIT FOR QUANTITATION HORMO
K Number: K813213
·
Decision Dec 22, 1981
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
142
Applicant Total
27
Review Days
43
Basic Information
- Device Name
- SHARIA-LH RIA KIT FOR QUANTITATION HORMO
- K Number
- K813213
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1485
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- INTL. IMMUNOASSAY LABORATORIES, INC.
- Date Received
- November 9, 1981
- Decision Date
- December 22, 1981
- Product Code
- CEP
- 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 |
|---|---|---|---|
| CEP | Radioimmunoassay, Luteinizing Hormone | FDA class 1 | Clinical Chemistry |
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Other Clearances by INTL. IMMUNOASSAY LABORATORIES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K913380 | MYDAS(TM)-MB2/MYDAS(TM)-MB | Apr 22, 1992 | Substantially Equivalent |
| K913349 | STAMBI-CK | Oct 23, 1991 | Substantially Equivalent |
| K912231 | PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT | Jul 8, 1991 | Substantially Equivalent |
| K903441 | MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS | Nov 6, 1990 | Substantially Equivalent |
| K903508 | LABELLING CHANGES TO IMPRES-MB-X | Sep 7, 1990 | Substantially Equivalent |
| K901450 | MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB | May 15, 1990 | Substantially Equivalent |
| K890609 | IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE) | Mar 16, 1989 | Substantially Equivalent |
| K890543 | IMPRES-MB REAGENT A AND REAGENT B | Mar 13, 1989 | Substantially Equivalent |
| K883432 | IMMUNOCCULT-LXI | Oct 31, 1988 | Substantially Equivalent |
| K883223 | CHECK-MM | Sep 30, 1988 | Substantially Equivalent |