FASTEC 901 AGGLUTINATION PATTERN READER
FDA 510(k) clearance K895967 · decided 1989-10-30
Clearance details
- K-number
- K895967
- Device name
- FASTEC 901 AGGLUTINATION PATTERN READER
- Applicant
- Schiff & Co.
- Decision
- Substantially Equivalent
- Date received
- 1989-10-12
- Decision date
- 1989-10-30
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- JJQ
- Device class
- 1
- Regulation number
- 862.2300
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- West Cadwell, NJ, US
- 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 |
|---|---|---|
| UBIT-IR300 INFRARED SPECTROMETRY SYSTEM (K013371) | Otsuka Pharmaceutical Co., Ltd. | 2001-12-21 |
| DIGENE DML 2000 MICROPLATE LUMINOMETER (K980120) | Digene Corp. | 1998-02-06 |
| ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER (K973938) | Sfri, Inc. | 1998-02-04 |
| STAT TRACKS (K974762) | Awareness Technology, Inc. | 1998-01-28 |
| ANTHOS PHACTS VERSION MICROPLATE READER (K962113) | Columbia Bioscience, Inc. | 1996-11-05 |
| CBI 7520 READER (K961183) | Columbia Bioscience, Inc. | 1996-08-02 |
| ORIGEN ANALYZER (K962166) | Igen, Inc. | 1996-07-31 |
| ANTHOS 2010 READER (K955077) | Anthos Labtec, Inc. | 1995-12-04 |
| ELX808 AUTOMATED MICROPLATE READERS (K953710) | Bio-Tek Instruments, Inc. | 1995-10-25 |
| ELX800UV (K953572) | Bio-Tek Instruments, Inc. | 1995-10-19 |
| BILI-METER (K953005) | Olympic Medical Corp. | 1995-09-28 |
| 5STRATEC SL 300 LIA-MAT (K950029) | Nichols Institute Diagnostics | 1995-08-02 |
Recalls involving this device
No recalls on record reference this clearance.