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510(k) K844877

HEPES BUFFER IM IN NORMAL SALINE by Hazleton Research Products, Inc. — Product Code KIP

K844877 is an FDA 510(k) premarket notification submitted by Hazleton Research Products, Inc. for the device "HEPES BUFFER IM IN NORMAL SALINE". The FDA issued a decision of Substantially Equivalent on February 25, 1985. The device falls under product code KIP (Formulations, Balanced Salt Solutions), a Class I device regulated under 21 CFR 864.2875. Hazleton Research Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1985
Date Received
December 17, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Formulations, Balanced Salt Solutions
Device Class
Class I
Regulation Number
864.2875
Review Panel
PA
Submission Type

Other clearances by Hazleton Research Products, Inc.

  • K861997 — PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE (June 10, 1986)
  • K861996 — DULBECCO'S MEM WITH 4.5 G/L GLUCOSE MEDIUM (June 9, 1986)
  • K861869 — GENTAMICIN-50MG/ML (May 29, 1986)
  • K861867 — MEM ALPHA EAGLE MEDIUM (May 29, 1986)
  • K861873 — MEM GLASGOW MEDIUM (May 29, 1986)
  • K861874 — MINIMUM ESSENTIAL MED. (EAGLE) W/25MM HEPES BUFFER (May 29, 1986)
  • K861887 — MEM GLASGOW POWDERED MEDIUM (May 29, 1986)
  • K861886 — DMEM & HAM'S F-12 (1:1) POWDERED MEDIUM (May 29, 1986)
  • K861871 — NCTC 109 MEDIUM (May 29, 1986)
  • K861868 — WILLIAMS MEDIUM E (May 29, 1986)

Other clearances for product code KIP

  • K870486 — EARLE'S BALANCED SALTS (EBSS) HYBRI-MAX #E9509 (March 30, 1987)
  • K870491 — KREBS-RINGER BICARBONATE BUFFER PRODUCT NO. K4002 (March 30, 1987)
  • K870484 — HANKS' BALANCED SALTS (HBSS) NO. H1387 (March 30, 1987)
  • K870482 — (D-PBS) MODIFIED HYBRI-MAX PRODUCT NO. D7030 (March 30, 1987)
  • K860784 — DULBECCO'S PHOSPHATE BUFFERED SALINE W/CALCL2 (March 12, 1986)
  • K844878 — TRYPSIN 10X - 1:250 IN HBSS W/O CA & MG (February 25, 1985)
  • K842724 — SALINE 0.85% W/O PRESERVATIVE (August 3, 1984)
  • K842723 — SALINE, 1.3% W/O PRESERVATIVE (August 3, 1984)
  • K842725 — SALINE, 0.85%W/PRESERVATIVE (August 3, 1984)
  • K820923 — DULBECCO'S PBS POWDER (April 21, 1982)

FDA data resources