Product code JRE— Clinical Chemistry
ATAGO URINE SPECIFIC GRAVITY & SERUM
- Classification name
- Refractometer For Clinical Use
- Device class
- Class 1
- Regulation
- 21 CFR 862.2800
- Advisory panel
- Clinical Chemistry
- Total cleared
- 13
- First cleared
- Most recent
Market context for product code JRE
FDA has cleared devices under product code JRE between 1979 and 1996, filed by 8 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
- 1996
- 1995
- 1994
- 1990
- 1984
- 1983
- 1981
- 1980
- 1979
Top applicants under product code JRE
Recent clearances under product code JRE
- K954977 — URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION)
- K941901 — MODEL 2721 CLINICAL REFRACTOMETER
- K941903 — MODEL 2740 CLINICAL REFRACTOMETER
- K941906 — MODEL 2730 CLINICAL REFRACTOMETER
- K941902 — MODEL 3471 CLINICAL REFRACTOMETER
- K941904 — MODEL A300CL CLINICAL REFRACTOMETER
- K941905 — MODEL 3461 CLINICAL REFRACTOMETER
- K891681 — DILECTRON URINARY CONDUCTIVITY PROBE
- K842168 — ATAGO URINE SPECIFIC GRAVITY & SERUM
- K831213 — SPECIFIC GRAVITY INSTRUMENT
- K811342 — REAGENT STRIPS FOR URINALYSIS
- K802959 — NIKON URINE REFRACTOMER SG-1
- K790862 — BIOVATION DIGITAL URINOMETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.