The following data is part of a premarket notification filed by Jerome Instrument Corp. with the FDA for Gold Film Mercury Analyzer #511.
Device ID | K832933 |
510k Number | K832933 |
Device Name: | GOLD FILM MERCURY ANALYZER #511 |
Classification | Mercury, Atomic Absorption |
Applicant | JEROME INSTRUMENT CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DPH |
CFR Regulation Number | 862.3600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-30 |
Decision Date | 1983-11-25 |