FLAME PHOTOMETER MODEL 460
FDA 510(k) clearance K771303 · decided 1977-08-22
Clearance details
- K-number
- K771303
- Device name
- FLAME PHOTOMETER MODEL 460
- Applicant
- Corning Medical & Scientific
- Decision
- Substantially Equivalent
- Date received
- 1977-07-15
- Decision date
- 1977-08-22
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- JIH
- Device class
- 2
- Regulation number
- 862.3560
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- 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 |
|---|---|---|
| MODIFICATION TO: INSTAREAD LITHIUM SYSTEM (K050338) | Akers Biosciences, Inc. | 2005-03-04 |
| INSTAREAD LITHIUM SYSTEM (K031579) | Akers Laboratories, Inc. | 2003-12-19 |
| DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132 (K011033) | Dade Behring, Inc. | 2001-06-07 |
| KODAK EKTACHEM DTSC II SLIDES (LI) (K934106) | Eastman Kodak Company | 1994-04-25 |
| KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI) (K924488) | Eastman Kodak Company | 1993-01-26 |
| MODEL 654 ANALYZER (K921403) | Ciba Corning Diagnostics Corp. | 1992-07-30 |
| AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE (K895465) | Baxter Healthcare Corp | 1989-12-27 |
| TDX(R) LITES(TM) LITHIUM (K894328) | Abbott Laboratories | 1989-11-13 |
| POTASSIUM DILUENT (K830636) | Shaban Mfg. Co. | 1983-04-05 |
| LITHIUM DILUENT (1500 MM/E) (K800039) | Gilford Diagnostics | 1980-01-21 |
| FLAME PHOTOMETER MOLEL 4600, KDA (K770824) | American Monitor Corp. | 1977-07-15 |
Recalls involving this device
No recalls on record reference this clearance.