Dilution Kit, Thermal, Cold Pac
FDA 510(k) K781221 · Instrumentation Laboratory CO
510(k) numberK781221
Submission
- Device name
- Dilution Kit, Thermal, Cold Pac
- Applicant
- Instrumentation Laboratory CO
Mchenry, IL, US - Received
- July 17, 1978
- Decision date
- August 23, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRC – Trocar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1390
- Specialty
- Cardiovascular
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Questions and answers
When was Dilution Kit, Thermal, Cold Pac cleared by the FDA?
Dilution Kit, Thermal, Cold Pac (K781221) received a 510(k) decision of Substantially Equivalent on August 23, 1978, 37 days after the submission was received.
What is the product code of K781221?
The FDA product code is DRC – Trocar, a Class II (moderate risk) device regulated under 21 CFR 870.1390.