Aia-Pack(R) Prog Assay
FDA 510(k) K933269 · Tosoh Medics, Inc.
510(k) numberK933269
Submission
- Device name
- Aia-Pack(R) Prog Assay
- Applicant
- Tosoh Medics, Inc.
Foster City, CA, US - Received
- July 6, 1993
- Decision date
- October 22, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JLS – Radioimmunoassay, Progesterone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1620
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JLS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K040923 | Luminescent Immunoassay Kit for the Detection of Progesterone in SalivaJLS · Traditional | Ibl GmbH | 07/22/2004SE |
| K973898 | Progesterone ElisaJLS · Traditional | Kmi Diagnostics, Inc. | 11/13/1997SE |
| K972133 | Vitros Immunodiagnostics Products Progesterone Reagent Pack (GEM.1070), Progesterone…JLS · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 06/24/1997SE |
| K971725 | Opus ProgesteroneJLS · Traditional | Behring Diagnostics, Inc. | 06/18/1997SE |
| K964841 | Elecsys Progesterone AssayJLS · Traditional | Boehringer Mannheim Corp. | 03/24/1997SE |
| K965084 | Vidas Proesterone (PRG) (30 409)JLS · Traditional | bioMerieux, Inc. | 01/09/1997SE |
| K955025 | Axsym ProgesteroneJLS · Traditional | Abbott Laboratories | 03/07/1996SE |
| K955769 | Access Progesterone AssayJLS · Traditional | Bio-Rad Laboratories, Inc. | 02/05/1996SE |
| K952075 | Progesterone Assay for the Technicon Immuno 1 System In-Bitro Diagnostic SystemJLS · Traditional | Bayer Corp. | 06/13/1995SE |
| K951630 | Auraflex Progesterone 150TEST PackJLS · Traditional | Organon Teknika Corp. | 05/08/1995SE |
More from Organon Teknika Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K023893 | ST Aia-Pack Cea Enzyme ImmunoassayDHX · Special | 12/18/2002SE |
| K023894 | ST Aia-Pack Afp Enzyme ImmunoassayLOJ · Special | 12/17/2002SE |
| K023091 | ST Aia-Pack Testosterone AssayCDZ · Traditional | 12/17/2002SE |
| K023891 | ST Aia-Pack Ca 125 Enzyme ImmunoassayLTK · Special | 12/06/2002SE |
| K020489 | G7 Automated HPLC Analyzer, Beta-Thalassemia ModeJPD · Traditional | 05/14/2002SE |
| K012820 | Aia-Pack Ctni 2ND-GEN AssayMMI · Traditional | 12/14/2001SE |
| K011434 | G7 Automated HPLC AnalyzerLCP · Traditional | 09/18/2001SE |
| K010796 | Aia-Pack Brca, ST Aia Pack BrcaMOI · Traditional | 08/16/2001SE |
| K992365 | Aia-Pack Folate AssayCGN · Traditional | 08/10/1999SE |
| K990431 | Aia-Pack Ca 125LTK · Traditional | 06/03/1999SE |
Questions and answers
When was Aia-Pack(R) Prog Assay cleared by the FDA?
Aia-Pack(R) Prog Assay (K933269) received a 510(k) decision of Substantially Equivalent on October 22, 1993, 108 days after the submission was received.
What is the product code of K933269?
The FDA product code is JLS – Radioimmunoassay, Progesterone, a Class I (low risk) device regulated under 21 CFR 862.1620.