Mid-Level Igg Kit Cat. No. 9315
FDA 510(k) K891299 · Helena Laboratories
510(k) numberK891299
Submission
- Device name
- Mid-Level Igg Kit Cat. No. 9315
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- March 13, 1989
- Decision date
- March 22, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DAQ – Igg (Fd Fragment Specific), Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5540
- Specialty
- Immunology
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Questions and answers
When was Mid-Level Igg Kit Cat. No. 9315 cleared by the FDA?
Mid-Level Igg Kit Cat. No. 9315 (K891299) received a 510(k) decision of Substantially Equivalent on March 22, 1989, 9 days after the submission was received.
What is the product code of K891299?
The FDA product code is DAQ – Igg (Fd Fragment Specific), Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5540.