TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY
FDA 510(k) clearance K972666 · decided 1997-09-11
Clearance details
- K-number
- K972666
- Device name
- TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY
- Applicant
- Hybritech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-07-16
- Decision date
- 1997-09-11
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- CIN
- Device class
- 2
- Regulation number
- 862.1050
- 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 |
|---|---|---|
| Access Ostase (K232904) | Beckman Coulter | 2024-04-15 |
| IDS-iSYS Ostase BAP (K200475) | Immunodiagnostic Systems , Ltd. | 2020-09-30 |
| ORION DIAGNOSTICA UNIQ PINP RIA (K043125) | Orion Diagnostica, OY | 2005-05-04 |
| SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346 (K020625) | Helena Laboratories | 2002-05-06 |
| HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132) (K011113) | Sebia | 2001-06-13 |
| ACCESS OSTASE IMMUNOENZYMETRIC ASSAY (K994278) | Beckman Coulter, Inc. | 2000-03-28 |
| ALKPHASE-B ASSAY KIT (K981373) | Metra Biosystems, Inc. | 1998-05-27 |
| OPUS BONE ALP (K964764) | Behring Diagnostics, Inc. | 1997-01-24 |
| TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY (K961573) | Hybritech, Inc. | 1996-08-19 |
| ALKPHASE-B ASSAY KIT (K952768) | Metra Biosystems, Inc. | 1995-08-24 |
| RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT (K934013) | Isolab, Inc. | 1994-04-26 |
| TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY (K930810) | Hybritech, Inc. | 1994-01-11 |
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 |