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510(k) K780413

LOW IIONIC STRENGTH SOLUTION by Pfizer, Inc. — Product Code KSG

K780413 is an FDA 510(k) premarket notification submitted by Pfizer, Inc. for the device "LOW IIONIC STRENGTH SOLUTION". The FDA issued a decision of Substantially Equivalent on April 24, 1978. The device falls under product code KSG (Media, Potentiating For In Vitro Diagnostic Use), a Class II device regulated under 21 CFR 864.9600. Pfizer, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 1978
Date Received
March 15, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Potentiating For In Vitro Diagnostic Use
Device Class
Class II
Regulation Number
864.9600
Review Panel
HE
Submission Type

Other clearances by Pfizer, Inc.

  • K181102 — ThermaCare Quick Therapy TENS (September 15, 2018)
  • K991620 — VISINE FOR CONTACTS (September 24, 1999)
  • K892264 — ORALCHEK SUPER-SOFT BRUSH (June 14, 1989)
  • K892360 — WATER JEL STERILE GEL-SOAKED BURN DRESSING (June 5, 1989)
  • K881378 — PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE (June 17, 1988)
  • K854726 — MEDI-WIPES UNITED ANTISEPTIC SKIN PREP (February 24, 1986)
  • K850413 — MEC HIP BOLT (July 15, 1985)
  • K850403 — MEC DISTAL FEMORAL BOLT (July 15, 1985)
  • K850443 — MEC ROD CONNECTOR (July 15, 1985)
  • K850840 — HOWMEDICA THREADED ACETABULAR COMPONENT (July 15, 1985)

Other clearances for product code KSG

  • K812565 — ELUTION SOLUTION (October 23, 1981)
  • K812222 — EM-X (September 23, 1981)
  • K800943 — PENTEX BOVINE ALBUMIN 30% SOLUTION (May 8, 1980)
  • K800189 — BOVINE ALBUMIN 22% & 30% SOLUTIONS (February 13, 1980)
  • K791791 — ORTHO ANTIBODY ENHANCEMENT SOLUTION (October 11, 1979)
  • K791113 — LOW IONIC STRENGTH SOLUTION (LISS) (June 28, 1979)
  • K790973 — LO-ION (June 15, 1979)
  • K790776 — DADE LOW IONIC STRENGTH SOLUITION (LISS) (May 23, 1979)
  • K790498 — LISS REAGENT (April 3, 1979)
  • K781435 — ORTHO LOW IONIC SOLUTION (September 14, 1978)

FDA data resources