TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY
FDA 510(k) clearance K870520 · decided 1987-03-10
Clearance details
- K-number
- K870520
- Device name
- TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY
- Applicant
- Hybritech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-02-06
- Decision date
- 1987-03-10
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- CGJ
- Device class
- 1
- Regulation number
- 862.1300
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Hybritech
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ONE STEP FSH MENOPAUSAL TEST (K052662) | Ind Diagnostic, Inc. | 2005-11-30 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| TANDEM(R) E CEA IMMUNORADIOMETRIC ASSAY (P840019/S012) | Hybritech, Inc. | 1996-03-07 |
| STRATUS (R) CEA FLUOROMETRIC ENZYME IMMUNOASSAY (P840019/S010) | Hybritech, Inc. | 1994-03-17 |
| TANDEM(R) R CEA IMMUNORADIOMETRIC ASSAY (P840019/S011) | Hybritech, Inc. | 1994-01-13 |
| TANDEM-R(R) CARCINOEMBRYONIC ANTIGEN (CEA) ASSAY (P840019/S009) | Hybritech, Inc. | 1990-04-17 |
| TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY (P840019/S008) | Hybritech, Inc. | 1989-12-13 |
| TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY (P840019/S007) | Hybritech, Inc. | 1989-09-06 |
| TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY (P840019/S006) | Hybritech, Inc. | 1987-04-30 |
| TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY (P840019/S005) | Hybritech, Inc. | 1986-11-05 |