Atlas FDA

MAYBE?MOM MINI OVULATION MICROSCOPE

FDA 510(k) clearance K013582 · decided 2003-01-16

Clearance details

K-number
K013582
Device name
MAYBE?MOM MINI OVULATION MICROSCOPE
Applicant
Maybe?Mom
Decision
Substantially Equivalent
Date received
2001-10-30
Decision date
2003-01-16
Days to decision
443 days
Clearance type
Traditional
Product code
CEP
Device class
1
Regulation number
862.1485
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Ramsey, NJ, 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.

RecordFirmDate
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 York2001-12-05
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)Phamatech1999-03-22
BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT (K983113)Syntron Bioresearch, Inc.1998-11-18
CLEARPLAN EASY OVULATION TEST (K981271)Unipath , Ltd.1998-06-25

Recalls involving this device

No recalls on record reference this clearance.