IRON SYSTEM PACK REAGENTS
FDA 510(k) clearance K892838 · decided 1989-06-16
Clearance details
- K-number
- K892838
- Device name
- IRON SYSTEM PACK REAGENTS
- Applicant
- Boehringer Mannheim Corp.
- Decision
- Substantially Equivalent
- Date received
- 1989-04-18
- Decision date
- 1989-06-16
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- JIY
- Device class
- 1
- Regulation number
- 862.1410
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Indianapolis, IN, 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 |
|---|---|---|
| DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR (K061793) | Dade Behring, Inc. | 2006-08-07 |
| DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85) (K060264) | Dade Behring, Inc. | 2006-03-08 |
| SENTINEL IRON LIQUID (K051115) | Sentinel Ch. Srl | 2005-08-25 |
| VITALAB IRON REAGENT (K033983) | Clinical Data, Inc. | 2004-05-21 |
| ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL) (K030528) | Clinical Data | 2003-06-17 |
| IRON-PC-SL ASSAY MODEL # 151-10, 151-26 (K020816) | Diagnostic Chemicals , Ltd. | 2002-05-14 |
| WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003 (K013097) | Wiener Laboratories Saic | 2001-11-13 |
| IRON (K981241) | Abbott Laboratories | 1998-05-01 |
| SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30 (K973933) | Diagnostic Chemicals , Ltd. | 1997-11-04 |
| IL TEST IRON (K972363) | Instrumentation Laboratory CO | 1997-08-15 |
| IRON REAGENT (K964913) | Derma Media Lab., Inc. | 1997-02-20 |
| TOTAL IRON (NITRO-PAPS) REAGENT SET (K961588) | Pointe Scientific, Inc., | 1996-11-18 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ENZYMUN TEST{R} CEA (P860058/S001) | Boehringer Mannheim Corp. | 1993-07-29 |
| ENZYMUN-TEST{R} AFP (P860044/S003) | Boehringer Mannheim Corp. | 1991-09-03 |
| ENZYMUN-TEST{R} AFP (P860044/S002) | Boehringer Mannheim Corp. | 1991-07-19 |
| ENZYMUN-TEST{R} AFP (P860044/S001) | Boehringer Mannheim Corp. | 1990-08-03 |
| MICUR-MIC SYSTEMS (P820073) | Boehringer Mannheim Corp. | 1983-06-29 |