EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93
FDA 510(k) clearance K871414 · decided 1987-04-23
Clearance details
- K-number
- K871414
- Device name
- EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93
- Applicant
- Em Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-04-08
- Decision date
- 1987-04-23
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- JMO
- Device class
- 1
- Regulation number
- 862.1415
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Gibbstown, NJ, 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 |
|---|
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| VITROS CHEMISTRY PRODUCTS DTIBC REAGENT (K052867) | Ortho-Clinical Diagnostics, Inc. | 2005-12-23 |
| OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524 (K041793) | Olympus America, Inc. | 2004-07-16 |
| WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002 (K013102) | Wiener Laboratories Saic | 2001-11-13 |
| BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) (K012340) | Bayer Corp. | 2001-10-01 |
| DIRECT TIBC KIT (K000781) | Reference Diagnostics, Inc. | 2000-05-02 |
| TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE (K994115) | Dade Behring, Inc. | 2000-01-28 |
| TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 (K991666) | A.P. Total Care, Inc. | 1999-06-30 |
| TOTAL IRON, MODELS FE 109-01, FE 109-02 (K991244) | A.P. Total Care, Inc. | 1999-05-25 |
| MAGNETIC TIBC KIT (K990216) | Reference Diagnostics, Inc. | 1999-02-16 |
| UIBC (K982041) | Abbott Laboratories | 1998-07-30 |
Recalls involving this device
No recalls on record reference this clearance.