FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DSL 1900
K Number: K830816
·
Decision Apr 12, 1983
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
41
Applicant Total
14
Review Days
28
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Basic Information
- Device Name
- DSL 1900
- K Number
- K830816
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1265
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Diagnostic Systems
- Date Received
- March 15, 1983
- Decision Date
- April 12, 1983
- Product Code
- CGI
- 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 |
|---|---|---|---|
| CGI | Radioimmunoassay, Estriol | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CGI), ordered by most recent decision date.
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AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL
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|---|---|---|---|
| K905146 | OLYMPUS URINE PH | Feb 4, 1991 | Substantially Equivalent |
| K893691 | EMDS CREATINE KINASE ITEM NIMBER 65411 | Aug 31, 1989 | Substantially Equivalent |
| K893692 | EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405 | Aug 21, 1989 | Substantially Equivalent |
| K893966 | HDL PRECIPITATING REAGENT | Jul 25, 1989 | Substantially Equivalent |
| K884993 | VISUAL BLOOD GLUCOSE TEST SYSTEM | Dec 29, 1988 | Substantially Equivalent |
| K881116 | EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641 | Jun 20, 1988 | Substantially Equivalent |
| K880787 | EASY-TEST LACTIC ACID (LA) | Mar 15, 1988 | Substantially Equivalent |
| K862403 | EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95 | Jul 11, 1986 | Substantially Equivalent |
| K854784 | ABSORBANCE (ABS) TEST PAK | Dec 19, 1985 | Substantially Equivalent |
| K853699 | EASY ANALYZER & EASY-TEST REAGENT | Sep 25, 1985 | Substantially Equivalent |