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510(k) K801506

CERTIFIED BLOOD BANK SALINE by Nobel Scientific Industries, Inc. — Product Code JCE

K801506 is an FDA 510(k) premarket notification submitted by Nobel Scientific Industries, Inc. for the device "CERTIFIED BLOOD BANK SALINE". The FDA issued a decision of Substantially Equivalent on July 28, 1980. The device falls under product code JCE (Solution, Isotonic), a Class I device regulated under 21 CFR 864.4010. Nobel Scientific Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1980
Date Received
June 30, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solution, Isotonic
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type

Other clearances by Nobel Scientific Industries, Inc.

  • K854717 — NSI ASTRA TM TOTAL PROTEIN REAGENT KIT, NSI #7928 (January 14, 1986)
  • K854716 — NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909 (January 7, 1986)
  • K854718 — NSI ASTRA TM ALBUMIN REAGENT KIT NSI ITEM # 7926 (December 19, 1985)
  • K850944 — NSI LYSING-D REAGENT -4000 ML (March 29, 1985)
  • K844782 — NSI ELT-D DILUTING FLUID 4000ML (March 5, 1985)
  • K823283 — FLUSHING SOLUTION (December 3, 1982)
  • K812866 — ASTRA REAGENT CONCENTRATE SYSTEM (December 17, 1981)
  • K810549 — THERMAL PRINTER PAPER (April 8, 1981)
  • K810550 — SILVER ANODE (April 8, 1981)
  • K802518 — BUN REAGENT ASTRA 4 & 8 ANALYZERS (November 12, 1980)

Other clearances for product code JCE

  • K842722 — BUFFERED SALINE (September 11, 1984)
  • K831200 — IMMUNOHEMATOLOGICAL SALINE #97139 (May 9, 1983)
  • K792101 — COUITER/CMS ISOTONIC BLOOD BANK SALINE (November 20, 1979)
  • K761183 — LYSING AGENT AF (January 17, 1977)
  • K761174 — PHYSIOLOGIC SALINE (0.85%) (January 10, 1977)
  • K761170 — BARBITAL SALINE BUFFER (January 10, 1977)

FDA data resources