DIALBUMIN
FDA 510(k) clearance K891544 · decided 1989-06-09
Clearance details
- K-number
- K891544
- Device name
- DIALBUMIN
- Applicant
- Exocell, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-03-17
- Decision date
- 1989-06-09
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- JIR
- Device class
- 1
- Regulation number
- 862.1645
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Philadelphia, PA, 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 |
|---|---|---|
| Minuteful-kidney test (K222921) | Healthy.Io, Ltd. | 2023-09-08 |
| Minuteful - kidney test (K210069) | Healthy.Io, Ltd. | 2022-07-06 |
| Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) (K150330) | ACON Laboratories, Inc. | 2015-04-30 |
| TECO MICROALBUMIN 2-1 COMBO STRIPS (K061419) | Teco Diagnostics | 2007-01-26 |
| IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25 (K022538) | Diagnostic Chemicals, Ltd. (Usa) | 2002-08-23 |
| URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING (K001810) | Flexsite Diagnostics, Inc. | 2000-08-14 |
| IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15 (K994035) | Diagnostic Chemicals , Ltd. | 2000-02-01 |
| NEW MULTIPLES REAGENT STRIPS (K992257) | Bayer Corp. | 1999-11-24 |
| MICROALBUSTIX REAGENT STRIPS (OTC) (K991315) | Bayer Corp. | 1999-11-12 |
| UALB (K983774) | Abbott Laboratories | 1999-01-28 |
| HEALTH CHECK URI-TEST PROTEIN IN URINE (K972960) | Tcpi, Inc. | 1998-10-07 |
| MICROALBUSTIX REAGENT STRIPS (K982219) | Bayer Corp. | 1998-08-12 |
Recalls involving this device
No recalls on record reference this clearance.