Submission Details
| 510(k) Number | K964762 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 27, 1996 |
| Decision Date | April 25, 1997 |
| Days to Decision | 149 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT
Apr 1997
Decision
149d
Days
Class 2
Risk
About This 510(k) Submission
K964762 is an FDA 510(k) clearance for the IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT, a Ceruloplasmin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDB), submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on April 25, 1997, 149 days after receiving the submission on November 27, 1996. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5210.
Device Classification
| Product Code | DDB — Ceruloplasmin, Antigen, Antiserum, Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5210 |
Manufacturer
Similar Devices — DDB Ceruloplasmin, Antigen, Antiserum, Control
All 18
K161508 · Beckman Coulter Ireland, Inc.
· Jan 2017
K122965 · The Binding Site Group , Ltd.
· Jun 2013
K053074 · Dade Behring, Inc.
· Mar 2006
K913668 · The Binding Site, Ltd.
· Dec 1991
K895377 · Kallestad Diag, A Div. of Erbamont, Inc.
· Sep 1989
K860138 · Sigma Diagnostics, Inc.
· Mar 1986
More from Beckman Instruments, Inc.
View all
K973448
· LGD · Sep 1998
K982250
· CEC · Jul 1998
K981403
· DKB · May 1998
K981354
· LOJ · May 1998
K980173
· JHI · Mar 1998