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510(k) K841423

SCOTTS TAP WATER SUBSTITUTE 7 by Reagent Laboratory, Inc. — Product Code JCC

K841423 is an FDA 510(k) premarket notification submitted by Reagent Laboratory, Inc. for the device "SCOTTS TAP WATER SUBSTITUTE 7". The FDA issued a decision of Substantially Equivalent on May 22, 1984. The device falls under product code JCC (Ph Buffer), a Class I device regulated under 21 CFR 864.4010. Reagent Laboratory, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1984
Date Received
April 5, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ph Buffer
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
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)
  • K843050 — GRAM STAIN (September 11, 1984)
  • K842785 — STAIN, METHYLENE BLUE-EOSIN (September 11, 1984)
  • K841847 — LITHIUM REAGENT (August 17, 1984)
  • K843051 — WRIGHTS STAIN SOLUTION (August 3, 1984)
  • K841800 — LYSING & HEMOGLOBIN REAGENT (May 31, 1984)

Other clearances for product code JCC

  • K842918 — SCOTTS TAP WATER SUBSTITUTE (September 11, 1984)
  • K842914 — WRIGHT STAIN BUFFER (September 7, 1984)
  • K811791 — PHOSPHATE BUFFERED SALINE (1X) (August 25, 1981)
  • K811251 — CITRATE BUFFER (May 21, 1981)
  • K792574 — MOPSO BUFFER (January 21, 1980)
  • K770508 — SMAC SYSTEM (May 9, 1977)

FDA data resources