The following data is part of a premarket notification filed by Applications Lab with the FDA for Spq Test System For Immunoglobulin M.
Device ID | K850586 |
510k Number | K850586 |
Device Name: | SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M |
Classification | Igm (mu Chain Specific), Antigen, Antiserum, Control |
Applicant | APPLICATIONS LAB 10 NONESUCH RD. Scarborough, ME 04074 |
Contact | Glenn R Irish |
Correspondent | Glenn R Irish APPLICATIONS LAB 10 NONESUCH RD. Scarborough, ME 04074 |
Product Code | DAO |
CFR Regulation Number | 866.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-02-13 |
Decision Date | 1985-03-14 |