SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB
FDA 510(k) clearance K920416 · decided 1992-04-08
Clearance details
- K-number
- K920416
- Device name
- SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB
- Applicant
- Behring Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-01-31
- Decision date
- 1992-04-08
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- LIB
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Somerville, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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| Record | Firm | Date |
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| OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV) (K023677) | Osmetech | 2003-01-29 |
| GULL ELISAWARE (K912558) | Gull Laboratories, Inc. | 1991-09-16 |
| CORNING EASY WASH ELISA PLATES (K872273) | Corning Medical & Scientific | 1987-07-07 |
| CELL LIFTER (K871559) | Corning Costar Corp. | 1987-05-15 |
| NORMAL SALINE STERILE (K864249) | Mds Laboratories, Inc. | 1987-03-31 |
| CORNING ELISA PLATES (K863789) | Corning Medical & Scientific | 1986-10-03 |
| MICROSCOPE SLIDES (K862112) | Abco Dealers, Inc. | 1986-06-13 |
| AUTO MASH (K854604) | Dynatech Corp. | 1985-12-06 |
| MULTI MASH 2000 (K854603) | Dynatech Corp. | 1985-12-06 |
| MINI MASH 2000 (K854602) | Dynatech Corp. | 1985-12-06 |
| IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES (K854423) | Dynatech Laboratories, Inc. | 1985-11-20 |
| MYWASHER 5 (K853285) | Scientific Sales Intl., Inc. | 1985-10-04 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OPUS(R) CEA TEST SYSTEM (P920021/S001) | Behring Diagnostics, Inc. | 1996-02-23 |