HYBRITECH DATA STATION
FDA 510(k) clearance K834300 · decided 1984-02-21
Clearance details
- K-number
- K834300
- Device name
- HYBRITECH DATA STATION
- Applicant
- Hybritech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-12-09
- Decision date
- 1984-02-21
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- JQP
- Device class
- 1
- Regulation number
- 862.2100
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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| MR7000 WITH TIME MANAGER SOFTWARE (TMS) (K934111) | Dynatech Laboratories, Inc. | 1994-11-02 |
| EXPRESSO CARTRIDGE (K923316) | Bio-Rad Laboratories, Inc. | 1993-02-23 |
| MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER (K893838) | Ciba Corning Diagnostics Corp. | 1989-08-31 |
| CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM (K892060) | Syva Co. | 1989-08-10 |
| COBAS MFC (K885292) | Roche Diagnostic Systems, Inc. | 1989-03-22 |
| RIA-QUICK (K881194) | Quantitative Technologies, Inc. | 1988-06-01 |
| V-MARC 88A COMPUTER (K871853) | V.Marc, A Div. of Pictorial, Inc. | 1987-07-16 |
| KALLESTAD QM300 PROTEIN ANALYSIS SYSTEM (K871339) | Kallestad Diag, A Div. of Erbamont, Inc. | 1987-05-15 |
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 |