The following data is part of a premarket notification filed by G.d. Searle And Co. with the FDA for Laser Immunonephelometric Analyzer.
Device ID | K772361 |
510k Number | K772361 |
Device Name: | LASER IMMUNONEPHELOMETRIC ANALYZER |
Classification | Nephelometer, For Clinical Use |
Applicant | G.D. SEARLE AND CO. 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 | 1977-12-27 |
Decision Date | 1978-01-30 |