510(k) K021409
- Device
- AT HOME OVULATION TEST, MODEL 9032
- Applicant
- PHAMATECH INC.
- 510(k) number
- K021409
- Product code
- CEP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-05-24
- Date received
- 2002-05-03
- Regulation
- 862.1485
- Classification name
- Radioimmunoassay, Luteinizing Hormone
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CARL A MONGIOVI
- Address
- 9530 Padgett St., #101-106 San Diego CA US 92126 92126
FDA Registration Numbers#
- 2025099
- 3013284090
- 2517506
- 2432235
- 3007111389
- 3033482477
- 8043510
- 3005333358
- 3005951403
- 3006198300
- 3022178699
- 3009984016
- 3002806944
- 3011989923
- 9680746
- 3009491259
- 1319436
- 1649661
- 3003829675
- 2060833
- 3002800697
- 3002809144
- 8010132
- 3008198807
- 9610240
- 8020790
- 2032682
- 2031229
- 3017894300
- 3016837106
- 3005094123
- 2029372
- 9610126
- 2245285
- 8020888
- 3007583565
- 2280705
- 1036362
- 3015341499
- 3017379203
- 3005360469
- 3017019647
- 8031673
- 3010220539
- 1832216
- 2032839
- 3013679502
- 2020726
- 1827821
- 3024463179
- 3033967997
- 3005984081
- 2246703
- 3006635320
- 8043909
- 2122870
- 3009335633
- 3003917514
- 3005529799
- 3014848805
- 3004569406
- 9612316
- 1222302
- 3005128563
- 3013160357
- 3005641941
- 3004434309
- 3003233791
- 3001034529
- 2031824
- 3003741796
- 1219913
- 1319681
Source Documents#
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 |
| 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 |
| K991466 | EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE) | Selfcare, Inc. | 1999-05-25 |
| K991386 | EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK) | 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 |
| K970467 | EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT | Excel Scientific, Inc. | 1997-03-18 |
Legacy Summary#
summary
FDA Review#
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