| Device Classification Name |
Mercury, Atomic Absorption
|
| 510(k) Number |
K832933 |
| Device Name |
GOLD FILM MERCURY ANALYZER #511 |
| Applicant |
| Jerome Instrument Corp. |
| 4221 Richmond Rd., NW |
|
Walker,
MI
49534
|
|
| Correspondent |
| Jerome Instrument Corp. |
| 4221 Richmond Rd., NW |
|
Walker,
MI
49534
|
|
| Regulation Number | 862.3600 |
| Classification Product Code |
|
| Date Received | 08/30/1983 |
| Decision Date | 11/25/1983 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Toxicology
|
| 510k Review Panel |
Clinical Chemistry
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|