HDL PRECIPITANT REAGENT SET
FDA 510(k) clearance K841056 · decided 1984-05-01
Clearance details
- K-number
- K841056
- Device name
- HDL PRECIPITANT REAGENT SET
- Applicant
- Medical Specialties, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-03-12
- Decision date
- 1984-05-01
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- JHM
- Device class
- 1
- Regulation number
- 862.1475
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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 |
|---|---|---|
| PICCOLO HDL-CAPILLARY TEST SYSTEM (K120662) | Abaxis, Inc. | 2012-04-24 |
| DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE (K081300) | Siemens Healthcare Diagnostics | 2008-07-02 |
| DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B (K073072) | Dade Behring, Inc. | 2008-02-21 |
| DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A (K032798) | Dade Behring, Inc. | 2003-10-30 |
| LDL CHOLESTEROL (AUTOMATED) (K022519) | Jas Diagnostics, Inc. | 2002-09-30 |
| DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARTRIDGE (K983849) | Dade Behring, Inc. | 1999-01-11 |
| ROCHE COBAS READY HDL CHOLESTEROL REAGENT (K902935) | Roche Diagnostic Systems, Inc. | 1990-09-27 |
| LYPOPROTEIN CHOLESTEROL TEST KIT (K780173) | Environmental Chemical Specialties | 1978-05-03 |
Recalls involving this device
No recalls on record reference this clearance.