Atlas FDA

PASCO MIC AND MIC/ID PANELS

FDA 510(k) clearance K973317 · decided 1997-11-14

Clearance details

K-number
K973317
Device name
PASCO MIC AND MIC/ID PANELS
Applicant
Pasco Laboratories, Inc.
Decision
Substantially Equivalent
Date received
1997-09-03
Decision date
1997-11-14
Days to decision
72 days
Clearance type
Traditional
Product code
LTT
Device class
2
Regulation number
866.1640
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Wheat Ridge, CO, 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
MIC ANTIBIOTIC TEST PANELS (N50494/S006)Pasco Laboratories, Inc.1983-11-02
MIC ANTIBIOTIC TEST PANELS (N50494/S011)Pasco Laboratories, Inc.1983-07-25
MIC ANTIBIOTIC TEST PANELS (N50494/S010)Pasco Laboratories, Inc.1983-07-08
MIC ANTIBIOTIC TEST PANELS (N50494/S008)Pasco Laboratories, Inc.1982-12-22
MIC ANTIBIOTIC TEST PANELS (N50494/S009)Pasco Laboratories, Inc.1982-12-01
MIC ANTIBIOTIC TEST PANELS (N50494/S007)Pasco Laboratories, Inc.1982-09-03
MIC ANTIBIOTIC TEST PANELS (N50494/S005)Pasco Laboratories, Inc.1982-06-30
MIC ANTIBIOTIC TEST PANELS (N50494/S004)Pasco Laboratories, Inc.1982-03-12