Paramax Ise Chloride Calibrator
FDA 510(k) K873743 · Baxter Healthcare Corp
510(k) numberK873743
Submission
- Device name
- Paramax Ise Chloride Calibrator
- Applicant
- Baxter Healthcare Corp
Santa Ana, CA, US - Received
- September 16, 1987
- Decision date
- December 14, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JIT – Calibrator, Secondary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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Questions and answers
When was Paramax Ise Chloride Calibrator cleared by the FDA?
Paramax Ise Chloride Calibrator (K873743) received a 510(k) decision of Substantially Equivalent on December 14, 1987, 89 days after the submission was received.
What is the product code of K873743?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.