Aia-Pack E2 Assay
FDA 510(k) K932084 · Tosoh Medics, Inc.
510(k) numberK932084
Submission
- Device name
- Aia-Pack E2 Assay
- Applicant
- Tosoh Medics, Inc.
Foster City, CA, US - Received
- April 30, 1993
- Decision date
- November 9, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CHP – Radioimmunoassay, Estradiol
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1260
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CHP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K041349 | Luminescent Immunoassay Kit for the Detection of Estradiol in Saliva and SerumCHP · Traditional | Ibl GmbH | 09/24/2004SE |
| K973901 | 17 B-Estradiol (Elisa)CHP · Traditional | Kmi Diagnostics, Inc. | 11/24/1997SE |
| K973743 | Access Estradiol Reagents on the Access Immunoassay AnalyzerCHP · Traditional | Beckman Instruments, Inc. | 10/31/1997SE |
| K970386 | Acs ESTADIOL-6 IICHP · Traditional | Chiron Diagnostics Corp. | 06/04/1997SE |
| K970643 | Vitros Immunodiagnostics Products Estradiol Reagent Pack(Gem. 1050)/ESTRADIOL…CHP · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 03/18/1997SE |
| K970126 | Access Estradiol Reagents on the Access Immunoassay Analyzer (33550,33540,33545)CHP · Traditional | Bio-Rad Laboratories, Inc. | 02/25/1997SE |
| K965109 | Elecsys Estradiol AssayCHP · Traditional | Boehringer Mannheim Corp. | 02/18/1997SE |
| K955647 | Vidas Estradiol II (E2II) AssayCHP · Traditional | Biomerieux Vitek, Inc. | 02/06/1996SE |
| K954697 | Ciba Corning Acs ESTRADIOL-6 AssayCHP · Traditional | Ciba Corning Diagnostics Corp. | 12/13/1995SE |
| K953605 | Ultra-Sensitive EstradiolCHP · Traditional | Diagnostic Systems Laboratories, Inc. | 10/02/1995SE |
More from Diagnostic Systems Laboratories, Inc.
| 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 E2 Assay cleared by the FDA?
Aia-Pack E2 Assay (K932084) received a 510(k) decision of Substantially Equivalent on November 9, 1993, 193 days after the submission was received.
What is the product code of K932084?
The FDA product code is CHP – Radioimmunoassay, Estradiol, a Class I (low risk) device regulated under 21 CFR 862.1260.