ENDO-STAPH TEICHOIC ACID ANTIBODY KIT
FDA 510(k) clearance K820531 · decided 1982-04-14
Clearance details
- K-number
- K820531
- Device name
- ENDO-STAPH TEICHOIC ACID ANTIBODY KIT
- Applicant
- Meridian Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-03-02
- Decision date
- 1982-04-14
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- LHT
- Device class
- 1
- Regulation number
- 866.3700
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Walker, MI, 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 |
|---|---|---|
| STAPHYLASE TEST (K874303) | Oxoid U.S.A., Inc. | 1987-11-06 |
| SERO-STAT R II STAPHYLOCOCCUS TEST (K863025) | Scott Laboratories, Inc. | 1986-09-15 |
| STAPHYLOCOCCUS LATEX AGGLUTINATION KIT (K820683) | American Scientific Products | 1982-04-14 |
| ACCU-STAPH (K820347) | Carr-Scarborough Microbiologicals, Inc. | 1982-03-04 |
| DIAGNOSTIC KITS & KIT COMPONENTS (K812434) | Diagnostica, Inc. | 1981-09-23 |
| RAT BLOOD IN ALSEVER'S, CITRATED (K812368) | Dutchland Laboratories, Inc. | 1981-09-09 |
| ADULT CHICKEN BLOOD IN ALSEVER'S, C., D. (K812374) | Dutchland Laboratories, Inc. | 1981-09-09 |
| SHEEP BLOOD IN ALSEVER'S, CITR., DEFIBR (K812376) | Dutchland Laboratories, Inc. | 1981-09-09 |
| GOOSE BLOOD IN ALSEVER'S, CITRATED (ACD) (K812367) | Dutchland Laboratories, Inc. | 1981-09-09 |
| RABBIT BLOOD IN ALSEVER'S, CITR., DEFIBR (K812373) | Dutchland Laboratories, Inc. | 1981-09-09 |
| BABY CHICK BLOOD IN ALSEVER'S (K812375) | Dutchland Laboratories, Inc. | 1981-09-09 |
| GUINEA PIG BLOOD IN ALSEVER'S, CIT., DEF (K812372) | Dutchland Laboratories, Inc. | 1981-09-09 |
Recalls involving this device
No recalls on record reference this clearance.