Home / 510(k) Clearances / K841183

510(k) K841183

SODIUM CHLORIDE SOLUTION BLOOD CELL by Reagent Laboratory, Inc. — Product Code FNW

K841183 is an FDA 510(k) premarket notification submitted by Reagent Laboratory, Inc. for the device "SODIUM CHLORIDE SOLUTION BLOOD CELL". The FDA issued a decision of Substantially Equivalent on May 21, 1984. The device falls under product code FNW (Pad, Kelly), a Class II device regulated under 21 CFR 878.4370. Reagent Laboratory, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1984
Date Received
March 20, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pad, Kelly
Device Class
Class II
Regulation Number
878.4370
Review Panel
SU
Submission Type

Other clearances by Reagent Laboratory, Inc.

  • K863502 — SOLUTION B- NA 50MEQ/L, K 40 MEQ/L (October 21, 1986)
  • K863503 — HEMOLYSE (October 3, 1986)
  • K863550 — POTASSIUM HYDROXIDE 10% W/V (October 2, 1986)
  • K860143 — URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE (February 10, 1986)
  • K842982 — FORMALIN BUFFERED (October 1, 1984)
  • K842785 — STAIN, METHYLENE BLUE-EOSIN (September 11, 1984)
  • K843050 — GRAM STAIN (September 11, 1984)
  • K841847 — LITHIUM REAGENT (August 17, 1984)
  • K843051 — WRIGHTS STAIN SOLUTION (August 3, 1984)
  • K841799 — CYANOMETHEMOGLOBIN REAGENT (May 31, 1984)

Other clearances for product code FNW

  • K831117 — MICROMAT W/VARIOUS MODELS (May 30, 1984)

FDA data resources