Honey Bee, Yellow Jacket, Paper Wasp, Imported Fire Ant
FDA 510(k) K943768 · Diagnostic Products Corp.
510(k) numberK943768
Submission
- Device name
- Honey Bee, Yellow Jacket, Paper Wasp, Imported Fire Ant
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- August 2, 1994
- Decision date
- March 6, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DHB – System, Test, Radioallergosorbent (Rast) Immunological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5750
- Specialty
- Immunology
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Questions and answers
When was Honey Bee, Yellow Jacket, Paper Wasp, Imported Fire Ant cleared by the FDA?
Honey Bee, Yellow Jacket, Paper Wasp, Imported Fire Ant (K943768) received a 510(k) decision of Substantially Equivalent on March 6, 1995, 216 days after the submission was received.
What is the product code of K943768?
The FDA product code is DHB – System, Test, Radioallergosorbent (Rast) Immunological, a Class II (moderate risk) device regulated under 21 CFR 866.5750.