BABY CHICK BLOOD IN ALSEVER'S
FDA 510(k) clearance K812375 · decided 1981-09-09
Clearance details
- K-number
- K812375
- Device name
- BABY CHICK BLOOD IN ALSEVER'S
- Applicant
- Dutchland Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-08-20
- Decision date
- 1981-09-09
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- LHT
- Device class
- 1
- Regulation number
- 866.3700
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, 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 |
| ENDO-STAPH TEICHOIC ACID ANTIBODY KIT (K820531) | Meridian Diagnostics, Inc. | 1982-04-14 |
| 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 |
| 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.