Positive Control Pad for Total Ige Test Dipstick
FDA 510(k) K910082 · Quidel Corp.
510(k) numberK910082
Submission
- Device name
- Positive Control Pad for Total Ige Test Dipstick
- Applicant
- Quidel Corp.
San Diego, CA, US - Received
- January 8, 1991
- Decision date
- March 12, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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Questions and answers
When was Positive Control Pad for Total Ige Test Dipstick cleared by the FDA?
Positive Control Pad for Total Ige Test Dipstick (K910082) received a 510(k) decision of Substantially Equivalent on March 12, 1991, 63 days after the submission was received.
What is the product code of K910082?
The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.