Home / 510(k) Clearances / K811722

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 Jul 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 91 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 15, 1981
Date Received
Jun 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
510(k) Exempt

Other clearances by Meridian Diagnostics, Inc.

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

Other clearances for product code HYI

  • K871286 — GRAM IODINE (Apr 8, 1987)
  • K842733 — GRAM IODINE (Aug 10, 1984)
  • K821977 — GRAMSTAIN SET (Jul 22, 1982)
  • K791711 — IMPROVED GRAM STAIN REAGENTS (Oct 17, 1979)
  • K781584 — GRAM STAIN KIT (Oct 10, 1978)

FDA data resources

Source: FDA 510(k) database entry for K811722. Report a data issue: hello@regdatalab.com.