FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VIDAS PROESTERONE (PRG) (30 409)
K Number: K965084
·
Decision Jan 9, 1997
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
56
Applicant Total
251
Review Days
21
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- VIDAS PROESTERONE (PRG) (30 409)
- K Number
- K965084
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1620
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- bioMerieux, Inc.
- Date Received
- December 19, 1996
- Decision Date
- January 9, 1997
- Product Code
- JLS
- 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 |
|---|---|---|---|
| JLS | Radioimmunoassay, Progesterone | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JLS), ordered by most recent decision date.
LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PROGESTERONE ELISA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
OPUS PROGESTERONE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ELECSYS PROGESTERONE ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AXSYM PROGESTERONE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by bioMerieux, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260282 | VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance | Apr 15, 2026 | Substantially Equivalent |
| K251579 | VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) | Aug 21, 2025 | Substantially Equivalent |
| K234012 | VITEK COMPACT PRO | Mar 14, 2025 | Substantially Equivalent |
| K232967 | VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) | Jun 12, 2024 | Substantially Equivalent |
| K232963 | VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) | Jun 7, 2024 | Substantially Equivalent |
| K240279 | VIDAS TBI (GFAP, UCH-L1) | May 1, 2024 | Substantially Equivalent |
| K234000 | VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) | Mar 11, 2024 | Substantially Equivalent |
| K232201 | VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin | Oct 23, 2023 | Substantially Equivalent |
| K230864 | VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin | Jul 5, 2023 | Substantially Equivalent |
| K222378 | VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL) | Jun 26, 2023 | Substantially Equivalent |