Micro-Elisa HLH Test Kit Monoclonal
FDA 510(k) K860333 · Bioclinical Systems, Inc.
510(k) numberK860333
Submission
- Device name
- Micro-Elisa HLH Test Kit Monoclonal
- Applicant
- Bioclinical Systems, Inc.
St.Louis, MO, US - Received
- January 29, 1986
- Decision date
- April 21, 1986
- 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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|---|---|---|---|
| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K950196 | Culture Media, for Isolation of Pathogenic NeisseriaJTY · Traditional | 06/30/1995SE |
| K945911 | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton AgarsJTZ · Traditional | 04/04/1995SE |
| K933122 | Microbiological Culture Media,Martin Lewis AgarJTY · Traditional | 02/09/1994SE |
| K933121 | Microbiological Culture Media,Chocolate AgarJTY · Traditional | 02/03/1994SE |
| K873086 | Round 1JXA · Traditional | 08/24/1987SE |
| K860334 | Visi-Check HLH Test MonoclonalCEP · Traditional | 04/21/1986SE |
| K855227 | Micro-Eia Theophylline Test Kit MonoclonalKLS · Traditional | 04/11/1986SE |
| K854059 | Micro-Elisa HCG Est Kit Visi-Check HCG Test Kit NoJHI · Traditional | 01/13/1986SE |
| K854379 | Micro-Elisa TSH Test Kit-Visi-Check TSH Test KitJLW · Traditional | 01/07/1986SE |
| K850257 | BCS Glucose Colorimetric TestCGA · Traditional | 03/05/1985SE |
Questions and answers
When was Micro-Elisa HLH Test Kit Monoclonal cleared by the FDA?
Micro-Elisa HLH Test Kit Monoclonal (K860333) received a 510(k) decision of Substantially Equivalent on April 21, 1986, 82 days after the submission was received.
What is the product code of K860333?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.