LH/FSH RADIOIMMUNOASSAY KIT
FDA 510(k) clearance K853837 · decided 1985-10-16
Clearance details
- K-number
- K853837
- Device name
- LH/FSH RADIOIMMUNOASSAY KIT
- Applicant
- Bioclinical Group
- Decision
- Substantially Equivalent
- Date received
- 1985-09-16
- Decision date
- 1985-10-16
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- CEP
- Device class
- 1
- Regulation number
- 862.1485
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Cambridge, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| MAYBE?MOM MINI OVULATION MICROSCOPE (K013582) | Maybe?Mom | 2003-01-16 |
| INSTANT-VIEW LH OVULATION PREDICTING TEST (K022829) | Alfa Scientific Designs, Inc. | 2002-11-05 |
| AT HOME OVULATION TEST, MODEL 9032 (K021409) | Phamatech, Inc. | 2002-05-24 |
| CLEARPLANE EASY OVULATION TEST (K013874) | Unipath , Ltd. | 2002-02-19 |
| TCI-31 LIFELONG OVULATION TESTER (K013323) | Tci New York | 2001-12-05 |
| QUIK-CHECK OVULATION PREDICTOR (K012252) | ACON Laboratories, Inc. | 2001-08-24 |
| SURE CHECK OVULATION PREDICTOR (K010244) | Chembio Diagnostic Systems, Inc. | 2001-05-02 |
| INVERNESS MEDICAL OVULATION PREDICTOR TEST (K002867) | Selfcare, Inc. | 2000-10-12 |
| EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE) (K991466) | Selfcare, Inc. | 1999-05-25 |
| EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK) (K991386) | Selfcare, Inc. | 1999-05-25 |
| OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031 (K990249) | Phamatech | 1999-03-22 |
| BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT (K983113) | Syntron Bioresearch, Inc. | 1998-11-18 |
Recalls involving this device
No recalls on record reference this clearance.