LH Quik Ria Kit
FDA 510(k) K840174 · Pacific Biotech, Inc.
510(k) numberK840174
Submission
- Device name
- LH Quik Ria Kit
- Applicant
- Pacific Biotech, Inc.
Mchenry, IL, US - Received
- January 17, 1984
- Decision date
- March 19, 1984
- 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
Other 510(k)s with product code CEP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K013582 | Maybe?Mom Mini Ovulation MicroscopeCEP · Traditional | Maybe?Mom | 01/16/2003SE |
| K022829 | Instant-View LH Ovulation Predicting TestCEP · Abbreviated | Alfa Scientific Designs, Inc. | 11/05/2002SE |
| K021409 | At Home Ovulation Test, Model 9032CEP · Special | Phamatech, Inc. | 05/24/2002SE |
| K013874 | Clearplane Easy Ovulation TestCEP · Traditional | Unipath , Ltd. | 02/19/2002SE |
| K013323 | TCI-31 Lifelong Ovulation TesterCEP · Traditional | Tci New York | 12/05/2001SE |
| K012252 | Quik-Check Ovulation PredictorCEP · Traditional | ACON Laboratories, Inc. | 08/24/2001SE |
| K010244 | Sure Check Ovulation PredictorCEP · Traditional | Chembio Diagnostic Systems, Inc. | 05/02/2001SE |
| K002867 | Inverness Medical Ovulation Predictor TestCEP · Special | Selfcare, Inc. | 10/12/2000SE |
| K991466 | Early Ovulation Predictor (Cassette), One Step Ovulation Predictor (Cassette), Ovulation…CEP · Traditional | Selfcare, Inc. | 05/25/1999SE |
| 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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|---|---|---|
| K924461 | Strep a Negative ControlGTZ · Traditional | 12/02/1993SE |
| K902510 | Cards O.S. MonoKTN · Traditional | 07/16/1990SE |
| K896482 | Perfect(Tm) One Step Early Pregnancy Test KitLCX · Traditional | 03/06/1990SE |
| K896221 | Cards O.S.(Tm) Strep aGTZ · Traditional | 12/13/1989SE |
| K895390 | Cards O.S. (TM) Hcg-UrineJHI · Traditional | 11/13/1989SE |
| K891770 | HCG Irma IIJHI · Traditional | 05/24/1989SE |
| K884616 | Firstday Early Pregnancy Testing Kit IIJHI · Traditional | 01/13/1989SE |
| K883742 | Modified TSH Irma KitJLW · Traditional | 01/03/1989SE |
| K884007 | Cards(Tm) MonoKTN · Traditional | 11/18/1988SE |
| K882895 | Modified Beta Quik Stat Eia KitDHA · Traditional | 10/12/1988SE |
Questions and answers
When was LH Quik Ria Kit cleared by the FDA?
LH Quik Ria Kit (K840174) received a 510(k) decision of Substantially Equivalent on March 19, 1984, 62 days after the submission was received.
What is the product code of K840174?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.