LYTETEK SYSTEM
FDA 510(k) clearance K770774 · decided 1977-07-11
Clearance details
- K-number
- K770774
- Device name
- LYTETEK SYSTEM
- Applicant
- Boehringer Mannheim Corp.
- Decision
- Substantially Equivalent
- Date received
- 1977-04-28
- Decision date
- 1977-07-11
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- JGT
- Device class
- 2
- Regulation number
- 862.1665
- 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 |
|---|---|---|
| TECHNICON RA SYSTEMS SODIUM (COLORIMETRIC METHOD) (K896829) | Technicon Instruments Corp. | 1990-02-23 |
| LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030 (K891574) | Em Diagnostic Systems, Inc. | 1989-06-09 |
| COMPONENTS FOR POTASSIUM, SODIUM CHLO (K841610) | Shaban Mfg. Co. | 1984-05-25 |
| SODIUM/POTASSIUM REAGENT SYS (K840216) | Sclavo, Inc. | 1984-03-19 |
| PARALLEL FLAME PHOTOMETER & SODIUM (K834248) | American Monitor Corp. | 1984-01-30 |
| CESIUM DILUENT 7.5M (K811886) | Gilford Diagnostics | 1981-07-23 |
| KLINAR REAGENT PAK, #36010 (K801892) | Hi Chem, Inc. | 1980-10-23 |
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 |