The following data is part of a premarket notification filed by Dynatech Corp. with the FDA for Nephelometer, Mic-2000 Laser.
Device ID | K790103 |
510k Number | K790103 |
Device Name: | NEPHELOMETER, MIC-2000 LASER |
Classification | Nephelometer, For Clinical Use |
Applicant | DYNATECH CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JQX |
CFR Regulation Number | 862.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-01-16 |
Decision Date | 1979-03-12 |