Clinistat Tda Series
FDA 510(k) K823112 · Miles Laboratories, Inc.
510(k) numberK823112
Submission
- Device name
- Clinistat Tda Series
- Applicant
- Miles Laboratories, Inc.
Mchenry, IL, US - Received
- October 21, 1982
- Decision date
- November 29, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KHO – Fluorometer, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2560
- Specialty
- Clinical Chemistry
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| K872634 | Cutter Pureflo Plus IV FilterFPB · Traditional | 08/04/1987SE |
| K870214 | Modified Saltex Reagent StripsCHK · Traditional | 06/29/1987SE |
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Questions and answers
When was Clinistat Tda Series cleared by the FDA?
Clinistat Tda Series (K823112) received a 510(k) decision of Substantially Equivalent on November 29, 1982, 39 days after the submission was received.
What is the product code of K823112?
The FDA product code is KHO – Fluorometer, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2560.