FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA
K Number: K962875
·
Decision Aug 23, 1996
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
41
Applicant Total
94
Review Days
30
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Basic Information
- Device Name
- ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA
- K Number
- K962875
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1265
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diagnostic Systems Laboratories, Inc.
- Date Received
- July 24, 1996
- Decision Date
- August 23, 1996
- 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
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|---|---|---|---|
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| K020128 | ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500 | Mar 1, 2002 | Substantially Equivalent |
| K002128 | ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100 | Dec 5, 2000 | Substantially Equivalent |
| K001086 | FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900 | May 18, 2000 | Substantially Equivalent |
| K990138 | DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 | Jun 21, 1999 | Substantially Equivalent |
| K981871 | C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100 | Nov 9, 1998 | Substantially Equivalent |
| K973243 | ACTIVE PSA ELISA (DSL-10-9700) | Aug 3, 1998 | Substantially Equivalent |
| K973244 | ACTIVE PSA IRMA (DSL-9700) | Aug 3, 1998 | Substantially Equivalent |
| K981607 | ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 | May 27, 1998 | Substantially Equivalent |