Home / 510(k) Clearances / K820037

510(k) K820037

SICKLE-CHECK by Diagnostic Technology, Inc. — Product Code JCM

K820037 is an FDA 510(k) premarket notification submitted by Diagnostic Technology, Inc. for the device "SICKLE-CHECK". The FDA issued a decision of Substantially Equivalent on February 4, 1982. The device falls under product code JCM (Control, Hemoglobin, Abnormal), a Class II device regulated under 21 CFR 864.7415. Diagnostic Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1982
Date Received
January 7, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Hemoglobin, Abnormal
Device Class
Class II
Regulation Number
864.7415
Review Panel
HE
Submission Type

Other clearances by Diagnostic Technology, Inc.

  • K896378 — LYME-CHECK(TM) TEST KIT (November 5, 1991)
  • K903612 — EBV/EA-CHECK TM TEST KIT (October 16, 1990)
  • K890819 — HSV-CHECK(TM) TEST KIT (June 20, 1989)
  • K890639 — RESUBMITTED EBV/IGM-CHECK TEST KIT (June 20, 1989)
  • K891542 — EBNA-CHECK(TM) TEST KIT (June 20, 1989)
  • K871373 — EBV-CHECK(TM) TEST KIT (IGG) (June 25, 1987)
  • K864128 — CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT (April 29, 1987)
  • K863408 — EBV/VCA-CHECK(TM) ANTIGEN SLIDES (November 28, 1986)
  • K860586 — PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS (May 7, 1986)
  • K860166 — PICOSCALE BLOOD CELL COUNTER, MODEL PS-5 (April 4, 1986)

Other clearances for product code JCM

  • K053031 — EXTENDSURE HBFASC CONTROL (December 7, 2005)
  • K011389 — HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL) (June 21, 2001)
  • K983704 — MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE (February 10, 1999)
  • K942222 — QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS (January 20, 1995)
  • K933086 — AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328 (October 31, 1994)
  • K931234 — HEMOCARD CONTROL HB-AA, AE, FAA, FAE (May 11, 1993)
  • K924173 — HEMOCARD(TM) CONTROL (December 1, 1992)
  • K913427 — SICKLE HEMOGLOBIN (HBA/S) CONTROL SET (November 19, 1991)
  • K911347 — LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL (June 10, 1991)
  • K910431 — HEMOCARD CONTROL (March 11, 1991)

FDA data resources