PC-CALIBRATOR— 510(k) K781133

Substantially Equivalent

Streck Laboratories, Inc.

FDA 510(k) clearance K781133 for PC-CALIBRATOR, Substantially Equivalent on 1978-08-14. Applicant: Streck Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Streck Laboratories, Inc.
Product code: Code KRY
Device class: Class 2
Regulation: 21 CFR 864.8175
Advisory panel: Hematology
Date received: 1978-07-06
Decision date: 1978-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KRY

K862122 — S-CAL HEMATOLOGY CALIBRATOR1987-05-20
K852016 — LASER PLATELETCAL/MULTIPLE1985-07-09
K843910 — COULTER MEAN PLATELET VOLUME CALIBRATOR1985-01-07
K840794 — S-CAL HEMATOLOGY CALIBRATOR1984-04-04
K821851 — CONTROL DIAGNOSTICS PLATELET CONTROL1982-09-02

More clearances from Streck Laboratories, Inc.

K042587 — RETIC-CHEX FOR CELL-DYN2004-10-19
K040107 — CYTO-CHEX BCT2004-07-27
K040025 — A1C-CELLULAR2004-03-02
K023656 — SICKLE-CHEX SOLUBILITY KIT2002-12-30
K021922 — MODIFICATION TO PARA 5X2002-06-25

Data sourced from openFDA. This site is unofficial and independent of the FDA.