EM-V
FDA 510(k) clearance K781397 · decided 1978-09-14
Clearance details
- K-number
- K781397
- Device name
- EM-V
- Applicant
- Biological Corp. of America
- Decision
- Substantially Equivalent
- Date received
- 1978-08-11
- Decision date
- 1978-09-14
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- KSG
- Device class
- 2
- Regulation number
- 864.9600
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- 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 |
|---|---|---|
| ELUTION SOLUTION (K812565) | Biological Corp. of America | 1981-10-23 |
| EM-X (K812222) | Biological Corp. of America | 1981-09-23 |
| PENTEX BOVINE ALBUMIN 30% SOLUTION (K800943) | Miles Laboratories, Inc. | 1980-05-08 |
| BOVINE ALBUMIN 22% & 30% SOLUTIONS (K800189) | Gotham Biologics, Inc. | 1980-02-13 |
| ORTHO ANTIBODY ENHANCEMENT SOLUTION (K791791) | Ortho Diagnostics, Inc. | 1979-10-11 |
| LOW IONIC STRENGTH SOLUTION (LISS) (K791113) | Hyland Therapeutic Div., Travenol Laboratories | 1979-06-28 |
| LO-ION (K790973) | Gamma Biologicals, Inc. | 1979-06-15 |
| DADE LOW IONIC STRENGTH SOLUITION (LISS) (K790776) | Dade, Baxter Travenol Diagnostics, Inc. | 1979-05-23 |
| LISS REAGENT (K790498) | Fisher Scientific Co., LLC | 1979-04-03 |
| ORTHO LOW IONIC SOLUTION (K781435) | Ortho Diagnostics, Inc. | 1978-09-14 |
| LOW IIONIC STRENGTH SOLUTION (K780413) | Pfizer, Inc. | 1978-04-24 |
| SPECT RIM (LISS) (K780556) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-04-24 |
Recalls involving this device
No recalls on record reference this clearance.