HLA CONTROL SERA
FDA 510(k) clearance K791118 · decided 1979-08-03
Clearance details
- K-number
- K791118
- Device name
- HLA CONTROL SERA
- Applicant
- Calbiochem-Behring Corp.
- Decision
- Substantially Equivalent
- Date received
- 1979-06-15
- Decision date
- 1979-08-03
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- LGO
- Device class
- 1
- Regulation number
- 864.7675
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Calbiochem-Behring Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PLATELIA TOXO IGG KIT (K894947) | Kallestad Diag, A Div. of Erbamont, Inc. | 1990-03-23 |
| SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT (K874544) | Molecular Biosystems, Inc. | 1988-08-12 |
| 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.