510(k) K050338
- Device
- MODIFICATION TO: INSTAREAD LITHIUM SYSTEM
- Applicant
- Akers Biosciences, Inc.
- 510(k) number
- K050338
- Product code
- JIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-03-04
- Date received
- 2005-02-11
- Regulation
- 862.3560
- Classification name
- Flame Photometry, Lithium
- Medical specialty
- Toxicology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ERIKA AMMIRATI
- Address
- 201 Grove Rd. Thorofare NJ US 08086 08086
FDA Registration Numbers#
- 3003030793
- 3012963943
- 3010825766
- 1319809
- 3002642396
- 2517506
- 1220972
- 2250051
- 9610126
- 1181121
- 3006198300
- 3003795116
- 1036362
- 3000308930
- 1319681
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JIH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K031579 | INSTAREAD LITHIUM SYSTEM | Akers Laboratories, Inc. | 2003-12-19 |
| K011033 | DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132 | Dade Behring, Inc. | 2001-06-07 |
| K934106 | KODAK EKTACHEM DTSC II SLIDES (LI) | Eastman Kodak Company | 1994-04-25 |
| K924488 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI) | Eastman Kodak Company | 1993-01-26 |
| K921403 | MODEL 654 ANALYZER | Ciba Corning Diagnostics Corp. | 1992-07-30 |
| K895465 | AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE | Baxter Healthcare Corp | 1989-12-27 |
| K894328 | TDX(R) LITES(TM) LITHIUM | Abbott Laboratories | 1989-11-13 |
| K830636 | POTASSIUM DILUENT | Shaban Mfg. Co. | 1983-04-05 |
| K800039 | LITHIUM DILUENT (1500 MM/E) | Gilford Diagnostics | 1980-01-21 |
| K771303 | FLAME PHOTOMETER MODEL 460 | Corning Medical & Scientific | 1977-08-22 |
| K770824 | FLAME PHOTOMETER MOLEL 4600, KDA | American Monitor Corp. | 1977-07-15 |
Legacy Summary#
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FDA Review#
Decision Summary