ONE STEP FSH MENOPAUSAL TEST
FDA 510(k) clearance K052662 · decided 2005-11-30
Clearance details
- K-number
- K052662
- Device name
- ONE STEP FSH MENOPAUSAL TEST
- Applicant
- Ind Diagnostic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-09-27
- Decision date
- 2005-11-30
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- CGJ
- Device class
- 1
- Regulation number
- 862.1300
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Delta, B.C., CA
- 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 |
|---|---|---|
| MOMENTS MENOPAUSE CHECK, MODEL 9113 (K043599) | Phamatech, Inc. | 2005-02-25 |
| FSH MENOPAUSE PREDICTOR TEST (K041165) | ACON Laboratories, Inc. | 2004-06-17 |
| PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112 (K040575) | Phamatech, Inc. | 2004-05-20 |
| EARLYDETECT MENOPAUSE TEST FOR FSH (K030058) | Early Detect, Inc. | 2003-07-30 |
| GENUA MENOPAUSE MONITOR TEST KIT (K002450) | Genua 1944, Inc. | 2001-01-12 |
| FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) (K972720) | Monobind | 1997-09-02 |
| SEALITE SCIENCES AQUALITE FSH (K970085) | Sealite Sciences, Inc. | 1997-02-14 |
| VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005) (K964720) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-02-04 |
| ELECSYS FSH ASSAY (K964693) | Boehringer Mannheim Corp. | 1996-12-16 |
| DSL ACTIVE FSH IRMA (K962118) | Diagnostic Systems Laboratories, Inc. | 1996-09-09 |
| AMERLITE FSH ASSAY (K952285) | Johnson & Johnson Clinical Diagnostics, Inc. | 1995-07-03 |
| AQUALITE FSH (K943437) | Sealite Sciences, Inc. | 1994-12-28 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DiagnosUS One Step FSH Menopausal Test (Strip) REF 210-07 recall (Z-0060-2024) | Universal Meditech Inc. | 2023-10-23 |