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510(k) K895745

SICKLE CELL SOLUBILITY TEST KIT by Simmler, Inc. — Product Code JBB

K895745 is an FDA 510(k) premarket notification submitted by Simmler, Inc. for the device "SICKLE CELL SOLUBILITY TEST KIT". The FDA issued a decision of Substantially Equivalent on November 29, 1989. The device falls under product code JBB (Solubility, Hemoglobin, Abnormal), a Class II device regulated under 21 CFR 864.7825. Simmler, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1989
Date Received
September 26, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solubility, Hemoglobin, Abnormal
Device Class
Class II
Regulation Number
864.7825
Review Panel
HE
Submission Type

Other clearances by Simmler, Inc.

  • K874903 — MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT) (February 11, 1988)
  • K874595 — MULTICHEM (R) MAGNESIUM REAGENT (January 21, 1988)
  • K874820 — MULTICHEM HDL PRECIPITATING REAGENT #S0914 (January 7, 1988)
  • K874812 — MULTICHEM CHLORIDE REAGENT S0933 (December 18, 1987)
  • K874311 — MULTICHEM (R) TOTAL BILIRUBIN (November 25, 1987)
  • K874049 — MULTICHEM ALBUMIN REAGENT S0902 (October 29, 1987)
  • K874038 — MULTICHEM INORGANIC PHOSPHOROUS S0923 (October 28, 1987)
  • K873725 — MULTICHEM CREATININE REAGENT S0917 (October 20, 1987)
  • K873761 — MULTICHEM ALKALINE PHOSPHATASE (S0903) (October 7, 1987)
  • K873697 — MULTICHEM CALCIUM S0910 (October 2, 1987)

Other clearances for product code JBB

  • K932872 — SICKLE CELL TEST KIT (August 16, 1993)

FDA data resources