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510(k) K821019

PHOSPHATE BUFFERED CLYCEROL MOUNTING FLU by Microbiological Research Corp. — Product Code LEB

K821019 is an FDA 510(k) premarket notification submitted by Microbiological Research Corp. for the device "PHOSPHATE BUFFERED CLYCEROL MOUNTING FLU". The FDA issued a decision of Substantially Equivalent on April 26, 1982. The device falls under product code LEB (Mounting Media), a Class I device regulated under 21 CFR 864.4010. Microbiological Research Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1982
Date Received
April 12, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mounting Media
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type

Other clearances by Microbiological Research Corp.

  • K883011 — MRI NEO-TRYP TRYPSIN RIA (April 26, 1989)
  • K861121 — THE GOLDEN QUAD TEST (EBV) (February 2, 1987)
  • K861120 — THE GOLDEN QUAD TEST (HSV) (February 2, 1987)
  • K861122 — THE GOLDEN QUAD TEST (TOXO) (February 2, 1987)
  • K861123 — THE GOLDEN QUAD TEST (CMV) (February 2, 1987)
  • K860450 — THE CMV-IGM TEST (May 13, 1986)
  • K843138 — CMV TEST (January 29, 1985)
  • K821018 — ANTIHUMAN IGG GLOBULIN FITC LABELED (April 29, 1982)
  • K803134 — TOXOPLASMA GONDII SEROLOGICAL REAGENTS (January 29, 1981)
  • K803175 — RUBELLA VIRUS SEROLOGICAL REAGENTS (January 29, 1981)

Other clearances for product code LEB

  • K842986 — REFRAX MOUNTING MEDIUM (August 21, 1984)
  • K812193 — KOH MOUNTING FLUID (August 31, 1981)
  • K811799 — CLEAR-MOUNT (July 31, 1981)
  • K760838 — LACTO-PHENOL COTTON BLUE MOUNTING FL. (November 16, 1976)

FDA data resources