Submission Details
| 510(k) Number | K993927 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 18, 1999 |
| Decision Date | January 14, 2000 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD
Jan 2000
Decision
57d
Days
Class 2
Risk
About This 510(k) Submission
K993927 is an FDA 510(k) clearance for the WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD, a Iga, Antigen, Antiserum, Control (Class II — Special Controls, product code CZP), submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on January 14, 2000, 57 days after receiving the submission on November 18, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.
Device Classification
| Product Code | CZP — Iga, Antigen, Antiserum, Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5510 |
Manufacturer
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