Product code CKD— Clinical Chemistry
SGPT REAGENT SET
- Classification name
- Hydrazone Colorimetry, Alt/Sgpt
- Device class
- Class 1
- Regulation
- 21 CFR 862.1030
- Advisory panel
- Clinical Chemistry
- Total cleared
- 11
- First cleared
- Most recent
Market context for product code CKD
FDA has cleared devices under product code CKD between 1982 and 1999, filed by 11 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1999
- 1995
- 1990
- 1988
- 1986
- 1984
- 1982
Top applicants under product code CKD
Recent clearances under product code CKD
- K991834 — CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772
- K941192 — ORTHO ALT MICROWELL TEST SYSTEM
- K896237 — COBAS READY ALT REAGENT
- K884784 — VIRGO(R) MICROWELL ALT ASSAY
- K883387 — ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD)
- K864082 — REFLOTRON(R) ALT (GPT)
- K860485 — SGPT (ALT) REAGENT SET (COLORIMETRIC)
- K844283 — SGPT REAGENT SET
- K841059 — SGPT REAGENT SET
- K821207 — SGPT REAGENT SET
- K820491 — SGPT REAGENT SET
Data sourced from openFDA. This site is unofficial and independent of the FDA.