Triglyceride Calibrator
FDA 510(k) K822852 · Harleco Diagnostics
510(k) numberK822852
Submission
- Device name
- Triglyceride Calibrator
- Applicant
- Harleco Diagnostics
Mchenry, IL, US - Received
- September 24, 1982
- Decision date
- October 27, 1982
- 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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| K821878 | Ultrazyme Plus LDHCFJ · Traditional | 07/14/1982SE |
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Questions and answers
When was Triglyceride Calibrator cleared by the FDA?
Triglyceride Calibrator (K822852) received a 510(k) decision of Substantially Equivalent on October 27, 1982, 33 days after the submission was received.
What is the product code of K822852?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.