The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for High Molecular Weight Kininogen(hmwk) Def Plasma.
Device ID | K861049 |
510k Number | K861049 |
Device Name: | HIGH MOLECULAR WEIGHT KININOGEN(HMWK) DEF PLASMA |
Classification | Test, Qualitative And Quantitative Factor Deficiency |
Applicant | SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
Contact | Leo Bressler |
Correspondent | Leo Bressler SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
Product Code | GGP |
CFR Regulation Number | 864.7290 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-03-19 |
Decision Date | 1986-05-29 |