CLP 0.02 M Calcium Chloride Solution.
FDA 510(k) K880711 · Creative Laboratory Products, Inc.
510(k) numberK880711
Submission
- Device name
- CLP 0.02 M Calcium Chloride Solution.
- Applicant
- Creative Laboratory Products, Inc.
Indianapolis, IN, US - Received
- February 22, 1988
- Decision date
- March 18, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GIT – Reagent & Control, Partial Thromboplastin Time
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7925
- Specialty
- Hematology
Other 510(k)s with product code GIT
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Questions and answers
When was CLP 0.02 M Calcium Chloride Solution. cleared by the FDA?
CLP 0.02 M Calcium Chloride Solution. (K880711) received a 510(k) decision of Substantially Equivalent on March 18, 1988, 25 days after the submission was received.
What is the product code of K880711?
The FDA product code is GIT – Reagent & Control, Partial Thromboplastin Time, a Class II (moderate risk) device regulated under 21 CFR 864.7925.