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510(k) K811722

PARA-PAK by Meridian Diagnostics, Inc. — Product Code HYI

K811722 is an FDA 510(k) premarket notification submitted by Meridian Diagnostics, Inc. for the device "PARA-PAK". The FDA issued a decision of Substantially Equivalent on July 15, 1981. The device falls under product code HYI (Iodine, Grams), a Class I device regulated under 21 CFR 864.1850. Meridian Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1981
Date Received
June 18, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Iodine, Grams
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type

Other clearances by Meridian Diagnostics, Inc.

  • K993914 — PREMIER TOXINS A&B, MODEL 616096 (December 10, 1999)
  • K990263 — IMMUNOCARD STAT! E. COLI O157:H7 (August 9, 1999)
  • K984343 — PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST (June 25, 1999)
  • K984346 — PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST (June 25, 1999)
  • K983255 — MODIFICATION TO: PREMIER PLATINUM HPSA (December 17, 1998)
  • K982764 — PREMIER CRYPTOSPORIDIUM (December 3, 1998)
  • K982711 — PREMIER GIARDIA (November 25, 1998)
  • K980076 — PREMIER PLATINUM HPSA (May 12, 1998)
  • K980077 — PARA-PAK SPINCON (April 2, 1998)
  • K971585 — IMMUNOCARD STAT! ROTAVIRUS (August 20, 1997)

Other clearances for product code HYI

  • K871286 — GRAM IODINE (April 8, 1987)
  • K842733 — GRAM IODINE (August 10, 1984)
  • K821977 — GRAMSTAIN SET (July 22, 1982)
  • K791711 — IMPROVED GRAM STAIN REAGENTS (October 17, 1979)
  • K781584 — GRAM STAIN KIT (October 10, 1978)

FDA data resources