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510(k) K822982

MIDAS 100 HEMACOLOR STAIN #66030 by Emd Chemicals, Inc. — Product Code HYB

K822982 is an FDA 510(k) premarket notification submitted by Emd Chemicals, Inc. for the device "MIDAS 100 HEMACOLOR STAIN #66030". The FDA issued a decision of Substantially Equivalent on October 27, 1982. The device falls under product code HYB (Eosin Y), a Class I device regulated under 21 CFR 864.1850. Emd Chemicals, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1982
Date Received
October 8, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Eosin Y
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type

Other clearances by Emd Chemicals, Inc.

  • K031367 — DUOPATH VEROTOXINS GLISA TEST (January 23, 2004)
  • K990516 — ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS (March 31, 1999)
  • K981926 — ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS (July 22, 1998)
  • K973054 — ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS (October 1, 1997)
  • K951494 — AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) (December 11, 1995)
  • K951750 — GLUCOSE TEST ITEM NUMBER 97375/94 (September 6, 1995)
  • K950234 — TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2 (June 14, 1995)
  • K950128 — TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 (May 15, 1995)
  • K945322 — PHOSPHORUS TEST (PHOS) ITEM NUMBER 65416 (December 7, 1994)
  • K945368 — PHOSPHORUS TEST (PHOS) (December 2, 1994)

Other clearances for product code HYB

  • K893663 — INSTANT EOSIN-AQUEOUS (June 13, 1989)
  • K880596 — EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINE (March 31, 1988)
  • K880240 — INSTANT EOSIN-ALCOHOLIC (March 3, 1988)
  • K843426 — EOSIN Y 1% ALCOHOLIC (September 27, 1984)
  • K821574 — EOSIN Y SOLUTIN, AGUEOUS (June 10, 1982)
  • K821573 — EOSIN Y SOLUTION ALCHOLIC (June 9, 1982)
  • K811797 — EOSIN-Y (July 28, 1981)
  • K811826 — EOSIN Y (July 10, 1981)
  • K800942 — VOLU-SOL EOSIN Y STAIN (May 8, 1980)

FDA data resources