Atlas FDA

LYME FAST TEST

FDA 510(k) clearance K883544 · decided 1989-01-13

Clearance details

K-number
K883544
Device name
LYME FAST TEST
Applicant
3M Company
Decision
Substantially Equivalent
Date received
1988-08-19
Decision date
1989-01-13
Days to decision
147 days
Clearance type
Traditional
Product code
LSR
Device class
2
Regulation number
866.3830
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Santa Clara, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S011)3M Company1994-11-28
CENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S010)3M Company1994-05-19
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S006)3M Company1992-12-31
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S009)3M Company1992-03-13
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S008)3M Company1992-01-28
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S007)3M Company1990-10-17
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S005)3M Company1990-03-08
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S004)3M Company1989-11-22