Estradiol Kit by Ria
FDA 510(k) K820329 · Immuchem Corp.
510(k) numberK820329
Submission
- Device name
- Estradiol Kit by Ria
- Applicant
- Immuchem Corp.
Mchenry, IL, US - Received
- February 8, 1982
- Decision date
- March 4, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
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| 510(k) | Device | Decision |
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| K883726 | Thyroid Stimulating Hormone (HTSH) Irma NeonatalJLW · Traditional | 12/15/1988SE |
| K871317 | Follicle Stimulating Hormone (HFSH)CGJ · Traditional | 05/20/1987SE |
| K871542 | Hprolactin KitCFT · Traditional | 05/14/1987SE |
| K865071 | Thyroid Stimulating Hormone (TSH Irma) Ria KitJLW · Traditional | 03/13/1987SE |
| K864144 | Luteinizing Hormone (Lh-Irma) Ria KitCEP · Traditional | 11/24/1986SE |
| K860559 | Androstenedione 125I Kit by RiaCIZ · Traditional | 03/14/1986SE |
| K854094 | Immuchem Covalent Coat a Solid Phase RadioimmunoasJLS · Traditional | 02/28/1986SE |
| K830962 | Immuchem Covalent-Coat Ria KitDPO · Traditional | 05/04/1983SE |
| K822509 | Covalent Coat Ria KitCFP · Traditional | 09/28/1982SE |
| K822140 | Immuchem Covalent-CoatJKC · Traditional | 08/05/1982SE |
Questions and answers
When was Estradiol Kit by Ria cleared by the FDA?
Estradiol Kit by Ria (K820329) received a 510(k) decision of Substantially Equivalent on March 4, 1982, 24 days after the submission was received.
What is the product code of K820329?
The FDA product code is CHP – Radioimmunoassay, Estradiol, a Class I (low risk) device regulated under 21 CFR 862.1260.