Sharia-Lh Ria Kit for Quantitation Hormo
FDA 510(k) K813213 · Intl. Immunoassay Laboratories, Inc.
510(k) numberK813213
Submission
- Device name
- Sharia-Lh Ria Kit for Quantitation Hormo
- Applicant
- Intl. Immunoassay Laboratories, Inc.
Mchenry, IL, US - Received
- November 9, 1981
- Decision date
- December 22, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CEP – Radioimmunoassay, Luteinizing Hormone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1485
- Specialty
- Clinical Chemistry
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| K991386 | Early Ovulation Predictor (Stick), One Step Ovulation Predictor (Stick), Ovulation…CEP · Traditional | Selfcare, Inc. | 05/25/1999SE |
More from Selfcare, Inc.
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| K912231 | Proposed New Use of Instrument System and Test KitJHW · Traditional | 07/08/1991SE |
| K903441 | Mydas(Tm) Brand Solid-Phase Antibody ReagentsJHX · Traditional | 11/06/1990SE |
| K903508 | Labelling Changes to Impres-Mb-XJHW · Traditional | 09/07/1990SE |
| K901450 | Modified Label for Embria-Ck, Quick-Mb/Micromi-MbJHT · Traditional | 05/15/1990SE |
| K890609 | Impres-Mb (Addition of an Optional Test Procedure)CGS · Traditional | 03/16/1989SE |
| K890543 | Impres-Mb Reagent a and Reagent BJHX · Traditional | 03/13/1989SE |
| K883432 | Immunoccult-LxiKHE · Traditional | 10/31/1988SE |
| K883223 | Check-MmJHS · Traditional | 09/30/1988SE |
Questions and answers
When was Sharia-Lh Ria Kit for Quantitation Hormo cleared by the FDA?
Sharia-Lh Ria Kit for Quantitation Hormo (K813213) received a 510(k) decision of Substantially Equivalent on December 22, 1981, 43 days after the submission was received.
What is the product code of K813213?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.