Submission Details
| 510(k) Number | K973055 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 15, 1997 |
| Decision Date | September 25, 1997 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
Cleared
Traditional
WAKO CH50 LINEARITY SET
Sep 1997
Decision
41d
Days
Class 2
Risk
About This 510(k) Submission
K973055 is an FDA 510(k) clearance for the WAKO CH50 LINEARITY SET, a Calibrator, Surrogate (Class II — Special Controls, product code JIW), submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on September 25, 1997, 41 days after receiving the submission on August 15, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1150.
Device Classification
| Product Code | JIW — Calibrator, Surrogate |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1150 |
Manufacturer
Similar Devices — JIW Calibrator, Surrogate
All 16
K970396 · Dade Chemistry Systems, Inc.
· Feb 1997
K910255 · Sigma Diagnostics, Inc.
· Apr 1991
K902575 · Diagnostic Products Corp.
· Oct 1990
K902294 · Sigma Chemical Co.
· Jul 1990
K892213 · Analytical Control Systems, Inc.
· Jun 1989
K883389 · Reagents Applications, Inc.
· Dec 1988
More from Wako Chemicals USA, Inc.
View all
K100464
· NSF · Feb 2011
K080125
· LBS · Jul 2008
K080123
· CFR · Jul 2008
K061775
· JFY · Feb 2007
K062368
· OAU · Jan 2007