510(k) K771144

RHODAMINE-CONJUGATED ANTISERUM by Kent Laboratories, Inc. — Product Code DBY

K771144 is an FDA 510(k) premarket notification submitted by Kent Laboratories, Inc. for the device "RHODAMINE-CONJUGATED ANTISERUM". The FDA issued a decision of Substantially Equivalent on July 14, 1977. The device falls under product code DBY (Fab, Rhodamine, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5520. Kent Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 14, 1977
Date Received: June 27, 1977
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Fab, Rhodamine, Antigen, Antiserum, Control
Device Class: Class I
Regulation Number: 866.5520
Review Panel: IM
Submission Type

Other clearances by Kent Laboratories, Inc.

K951966 — HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT (June 1, 1995)
K951967 — HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT (May 30, 1995)
K951968 — HUMAN C1Q RADIAL IMMUNODIFFUSION KIT (May 30, 1995)
K950102 — HUMAN C-5 RADIAL IMMUNODIFFUSION KIT (April 10, 1995)
K850683 — 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2 (November 27, 1985)
K850682 — 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL (November 25, 1985)
K850686 — ANTISERUM TO HUMAN PREALBUMIN (November 1, 1985)
K850691 — ANTISERUM TO HUMAN APOLIPOPROTEIN A-I (November 1, 1985)
K850690 — ANTISERUM TO HUMAN APOLIPOPROTEIN B (November 1, 1985)
K831961 — IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN (August 11, 1983)

510(k) K771144

Clearance Details

Device Classification

Other clearances by Kent Laboratories, Inc.

Other clearances for product code DBY

FDA data resources