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510(k) K812274

AURAMINE O MYCROBACTERIAL STAIN SET by Carr-Scarborough Microbiologicals, Inc. — Product Code KJK

K812274 is an FDA 510(k) premarket notification submitted by Carr-Scarborough Microbiologicals, Inc. for the device "AURAMINE O MYCROBACTERIAL STAIN SET". The FDA issued a decision of Substantially Equivalent on September 1, 1981. The device falls under product code KJK (Auramine O), 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
September 1, 1981
Date Received
August 13, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Auramine O
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 KJK

  • K853081 — AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET (August 13, 1985)

FDA data resources