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510(k) K791711

IMPROVED GRAM STAIN REAGENTS by Carr-Scarborough Microbiologicals, Inc. — Product Code HYI

K791711 is an FDA 510(k) premarket notification submitted by Carr-Scarborough Microbiologicals, Inc. for the device "IMPROVED GRAM STAIN REAGENTS". The FDA issued a decision of Substantially Equivalent on October 17, 1979. The device falls under product code HYI (Iodine, Grams), a Class I device regulated under 21 CFR 864.1850. Carr-Scarborough Microbiologicals, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1979
Date Received
August 28, 1979
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 Carr-Scarborough Microbiologicals, Inc.

  • K944554 — BRAIN HEART INFUSION AGAR (October 4, 1994)
  • K941985 — MUELLER HINTON AGAR W/OXACILLIN (August 24, 1994)
  • K905472 — LAP DISCS (February 27, 1991)
  • K905666 — M. CAT. BUTYRATE DISC (February 26, 1991)
  • K891476 — C. ALBICANS SCREEN (April 12, 1989)
  • K882636 — ALN DISCS (February 16, 1989)
  • K882630 — PRO DISCS (February 16, 1989)
  • K863216 — NEIS NZY (September 15, 1986)
  • K860301 — RAPID GLUTAMIC ACID DECARBOXYLASE (GDC) MICROTUBE (February 6, 1986)
  • K860302 — PYR DISCS (February 5, 1986)

Other clearances for product code HYI

  • K871286 — GRAM IODINE (April 8, 1987)
  • K842733 — GRAM IODINE (August 10, 1984)
  • K821977 — GRAMSTAIN SET (July 22, 1982)
  • K811722 — PARA-PAK (July 15, 1981)
  • K781584 — GRAM STAIN KIT (October 10, 1978)

FDA data resources