510(k) K964925
- Device
- SEALITE SCIENCES, INC. AQUALITE LH
- Applicant
- SEALITE SCIENCES, INC.
- 510(k) number
- K964925
- Product code
- CEP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-01-22
- Date received
- 1996-12-09
- Regulation
- 862.1485
- Classification name
- Radioimmunoassay, Luteinizing Hormone
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Clearance type
- Traditional
- Third party reviewed
- No
Other 510(k) Records For Product Code CEP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K013582 | MAYBE?MOM MINI OVULATION MICROSCOPE | Maybe?Mom | 2003-01-16 |
| K022829 | INSTANT-VIEW LH OVULATION PREDICTING TEST | Alfa Scientific Designs, Inc. | 2002-11-05 |
| K021409 | AT HOME OVULATION TEST, MODEL 9032 | Phamatech, Inc. | 2002-05-24 |
| K013874 | CLEARPLANE EASY OVULATION TEST | Unipath , Ltd. | 2002-02-19 |
| K013323 | TCI-31 LIFELONG OVULATION TESTER | Tci New York | 2001-12-05 |
| K012252 | QUIK-CHECK OVULATION PREDICTOR | ACON Laboratories, Inc. | 2001-08-24 |
| K010244 | SURE CHECK OVULATION PREDICTOR | Chembio Diagnostic Systems, Inc. | 2001-05-02 |
| K002867 | INVERNESS MEDICAL OVULATION PREDICTOR TEST | Selfcare, Inc. | 2000-10-12 |
| K991386 | EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK) | Selfcare, Inc. | 1999-05-25 |
| K991466 | EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE) | Selfcare, Inc. | 1999-05-25 |
| K990249 | OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031 | Phamatech | 1999-03-22 |
| K983113 | BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT | Syntron Bioresearch, Inc. | 1998-11-18 |
| K981271 | CLEARPLAN EASY OVULATION TEST | Unipath , Ltd. | 1998-06-25 |
| K974508 | DBEST ONE-STEP OVULATION TEST | Ameritek, Inc. | 1998-02-02 |
| K973310 | TBD* ONE-STEP OVULATION PREDICTOR TEST | Armkel, LLC | 1997-10-27 |
Legacy Summary#
summary
FDA Review#
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