PLATELIA TOXO IGG KIT
FDA 510(k) clearance K894947 · decided 1990-03-23
Clearance details
- K-number
- K894947
- Device name
- PLATELIA TOXO IGG KIT
- Applicant
- Kallestad Diag, A Div. of Erbamont, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-08-03
- Decision date
- 1990-03-23
- Days to decision
- 232 days
- Clearance type
- Traditional
- Product code
- LGO
- Device class
- 1
- Regulation number
- 864.7675
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Chaska, MN, 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 |
|---|---|---|
| SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT (K874544) | Molecular Biosystems, Inc. | 1988-08-12 |
| HLA CONTROL SERA (K791118) | Calbiochem-Behring Corp. | 1979-08-03 |
| LYMPHOCYTE TYPING, NEGATIVE CONTROL (K761008) | Hyland Therapeutic Div., Travenol Laboratories | 1977-04-06 |
| LYMPHOCYTE TYPING, POSITIVE CONTROL (K761009) | Hyland Therapeutic Div., Travenol Laboratories | 1977-04-06 |
Recalls involving this device
No recalls on record reference this clearance.