Acs Total Ige Immunoassay
FDA 510(k) K920372 · Ciba Corning Diagnostics Corp.
510(k) numberK920372
Submission
- Device name
- Acs Total Ige Immunoassay
- Applicant
- Ciba Corning Diagnostics Corp.
East Walpole, MA, US - Received
- January 28, 1992
- Decision date
- April 8, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DGC – Ige, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
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| K962041 | Acs LH2 ImmunoassayCEP · Traditional | 06/21/1996SE |
| K961510 | Acs FRT4 ImmunoassayJJX · Traditional | 06/17/1996SE |
| K960246 | Liquid Cardiac Marker 1,2,3 AssayedJJT · Traditional | 04/23/1996SE |
| K955873 | Acs Phenytoin AssayLGR · Traditional | 03/11/1996SE |
Questions and answers
When was Acs Total Ige Immunoassay cleared by the FDA?
Acs Total Ige Immunoassay (K920372) received a 510(k) decision of Substantially Equivalent on April 8, 1992, 71 days after the submission was received.
What is the product code of K920372?
The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.