SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT
FDA 510(k) clearance K874544 · decided 1988-08-12
Clearance details
- K-number
- K874544
- Device name
- SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT
- Applicant
- Molecular Biosystems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-11-03
- Decision date
- 1988-08-12
- Days to decision
- 283 days
- Clearance type
- Traditional
- Product code
- LGO
- Device class
- 1
- Regulation number
- 864.7675
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- San Diego, CA, 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 |
|---|---|---|
| PLATELIA TOXO IGG KIT (K894947) | Kallestad Diag, A Div. of Erbamont, Inc. | 1990-03-23 |
| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ALBUNEX(R) ALBUMIN (HUMAN) 5%, SONICATED (P900059/S004) | Molecular Biosystems, Inc. | 1997-06-17 |
| ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES (P900059/S002) | Molecular Biosystems, Inc. | 1996-03-01 |
| ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES (P900059/S003) | Molecular Biosystems, Inc. | 1995-08-28 |
| ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES (P900059/S001) | Molecular Biosystems, Inc. | 1995-07-31 |