Atlas FDA

FISHER DIAGNOSTICS HEMATALL III LAS REAGENT

FDA 510(k) clearance K874054 · decided 1987-10-20

Clearance details

K-number
K874054
Device name
FISHER DIAGNOSTICS HEMATALL III LAS REAGENT
Applicant
Fisher Scientific Co., LLC
Decision
Substantially Equivalent
Date received
1987-10-05
Decision date
1987-10-20
Days to decision
15 days
Clearance type
Traditional
Product code
GGK
Device class
1
Regulation number
864.8540
Medical specialty
Hematology
Advisory committee
Hematology
Location
Orangeburg, NY, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II (K883836)Coulter Immunology1988-11-30
KVM HEMOGLOBIN LYSING REAGENT (K883991)Kvm Technologies, Inc.1988-10-12
CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG. (K873348)Abbott Diagnostics1987-09-09
PIASTRINIT (K863114)J. D. Assoc.1986-11-06
HEMOLYSE (K863503)Reagent Laboratory, Inc.1986-10-03
NSI LYSING-D REAGENT -4000 ML (K850944)Nobel Scientific Industries, Inc.1985-03-29
LASER-LYSE (K850097)Hematology Marketing Assoc.1985-03-29
ACETIC ACID 1% V/V (K842938)E K Ind., Inc.1984-09-14
ACETIC ACID 2% V/V (K842937)E K Ind., Inc.1984-09-12
ACETIC ACID, 3% V/V (K842936)E K Ind., Inc.1984-09-12
ACETIC ACID, 5% V/V (K842935)E K Ind., Inc.1984-09-12
IDL-LYSING REAGENT (K842069)Interscience Diagnostics, Inc.1984-07-02

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
FLUORESCENT GONORRHEA TEST-HEATED (FGT-H) (P770001)Fisher Scientific Co., LLC1979-07-18