510(k) K052662
- Device
- ONE STEP FSH MENOPAUSAL TEST
- Applicant
- IND DIAGNOSTIC INC.
- 510(k) number
- K052662
- Product code
- CGJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-11-30
- Date received
- 2005-09-27
- Regulation
- 862.1300
- Classification name
- Radioimmunoassay, Follicle-stimulating Hormone
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JASON PENG
- Address
- 1629 Fosters Way Delta, B.C. CA V3M 6S7 V3M 6S7
FDA Registration Numbers#
- 3017019647
- 8010132
- 3005094123
- 3006198300
- 3009984016
- 3002800697
- 9680746
- 3017894300
- 2245285
- 3005333358
- 1319436
- 3003741796
- 3022178699
- 3031915160
- 2432235
- 3012963943
- 3004434309
- 2250051
- 1832216
- 3002809144
- 9612316
- 3009491259
- 2020726
- 1222302
- 1036362
- 2517506
- 2122870
- 8031673
- 1827821
- 3011989923
- 3008198807
- 2032682
- 3033967997
- 3002642396
- 3005984081
- 8020888
- 1219913
- 9610240
- 3005529799
- 2031229
- 3007111389
- 9610126
- 2029372
- 1319681
- 3000308930
- 3017379203
- 3002806944
- 8020790
- 2032839
- 3004192065
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CGJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K043599 | MOMENTS MENOPAUSE CHECK, MODEL 9113 | Phamatech, Inc. | 2005-02-25 |
| K041165 | FSH MENOPAUSE PREDICTOR TEST | ACON Laboratories, Inc. | 2004-06-17 |
| K040575 | PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112 | Phamatech, Inc. | 2004-05-20 |
| K030058 | EARLYDETECT MENOPAUSE TEST FOR FSH | Early Detect, Inc. | 2003-07-30 |
| K002450 | GENUA MENOPAUSE MONITOR TEST KIT | Genua 1944, Inc. | 2001-01-12 |
| K972720 | FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) | Monobind | 1997-09-02 |
| K970085 | SEALITE SCIENCES AQUALITE FSH | Sealite Sciences, Inc. | 1997-02-14 |
| K964720 | VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-02-04 |
| K964693 | ELECSYS FSH ASSAY | Boehringer Mannheim Corp. | 1996-12-16 |
| K962118 | DSL ACTIVE FSH IRMA | Diagnostic Systems Laboratories, Inc. | 1996-09-09 |
| K952285 | AMERLITE FSH ASSAY | Johnson & Johnson Clinical Diagnostics, Inc. | 1995-07-03 |
| K943437 | AQUALITE FSH | Sealite Sciences, Inc. | 1994-12-28 |
| K941221 | DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONE | Dupont Medical Products | 1994-07-20 |
| K935612 | AXSYM FOLLICLE STIMULATING HORMONE (FSH) | Abbott Laboratories | 1994-06-21 |
| K940005 | ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY | Bio-Rad Laboratories, Inc. | 1994-03-03 |
Legacy Summary#
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FDA Review#
Decision Summary