FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VIDAS ESTRADIOL (E2) ASSAY
K Number: K925498
·
Decision Feb 12, 1993
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
49
Applicant Total
49
Review Days
105
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Basic Information
- Device Name
- VIDAS ESTRADIOL (E2) ASSAY
- K Number
- K925498
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1260
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomerieux Vitek, Inc.
- Date Received
- October 30, 1992
- Decision Date
- February 12, 1993
- Product Code
- CHP
- 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 |
|---|---|---|---|
| CHP | Radioimmunoassay, Estradiol | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CHP), ordered by most recent decision date.
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·Clinical Chemistry
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Biomerieux Vitek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973819 | VIDAS D-DIMER (DD) ASSAY | Mar 10, 1998 | Substantially Equivalent |
| K972895 | VIDAS ROTAVIRUS (RTV) ASSAY | Oct 3, 1997 | Substantially Equivalent |
| K965092 | VIDAS ROTAVIRUS ASSAY | May 5, 1997 | Substantially Equivalent |
| K964887 | VIDAS C. DIFFICILE TOXIN A II ASSAY | Apr 8, 1997 | Substantially Equivalent |
| K955627 | VIDAS CHLAMYDIA BLOCKING ASSAY | Oct 7, 1996 | Substantially Equivalent |
| K962549 | VIDAS CREATINE KINASE MB ASSAY 30-421 | Aug 30, 1996 | Substantially Equivalent |
| K962609 | GRAM NEGATIVE IDENTIFICATION PLUS CARD | Aug 30, 1996 | Substantially Equivalent |
| K952095 | VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) | Mar 12, 1996 | Substantially Equivalent |
| K955647 | VIDAS ESTRADIOL II (E2II) ASSAY | Feb 6, 1996 | Substantially Equivalent |
| K943812 | VIDAS LYME SCREEN II | Jun 13, 1995 | Substantially Equivalent |