ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK
FDA 510(k) clearance K914226 · decided 1991-11-19
Clearance details
- K-number
- K914226
- Device name
- ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-09-20
- Decision date
- 1991-11-19
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- JZB
- Device class
- 1
- Regulation number
- 874.4420
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Wilmington, DE, 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 |
|---|---|---|
| VEIN GRAFT EAR SCISSORS (K870756) | Treace Medical, Inc. | 1987-03-03 |
| SCISSORS SHEA BELLUCC (K833603) | Microtek Medical, Inc. | 1984-01-03 |
| EAR SCISSORS (K822196) | Kelleher Corp. | 1982-08-30 |
Recalls involving this device
No recalls on record reference this clearance.