Heating Block, Wampole 37 C
FDA 510(k) K790549 · Armkel, LLC
510(k) numberK790549
Submission
- Device name
- Heating Block, Wampole 37 C
- Applicant
- Armkel, LLC
Mchenry, IL, US - Received
- March 20, 1979
- Decision date
- May 3, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JRG – Block, Heating
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2050
- Specialty
- Clinical Chemistry
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Questions and answers
When was Heating Block, Wampole 37 C cleared by the FDA?
Heating Block, Wampole 37 C (K790549) received a 510(k) decision of Substantially Equivalent on May 3, 1979, 44 days after the submission was received.
What is the product code of K790549?
The FDA product code is JRG – Block, Heating, a Class I (low risk) device regulated under 21 CFR 862.2050.