Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

American Micro Scan — Predicate Candidate Screening

24 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

59 daysmedian FDA review time

130 days90th percentile

24clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K870029	IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE	American Micro Scan	1987-03-25	79	0
K864662	CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS	American Micro Scan	1987-03-25	117	0
K863776	MICRODILUTION MIC PANELS	American Micro Scan	1987-02-02	130	0
K864674	MICRODILUTION IDENTIFICATION PANELS	American Micro Scan	1987-01-05	34	0
K864389	CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST	American Micro Scan	1986-12-04	28	0
K863038	GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL	American Micro Scan	1986-09-30	49	0
K862642	GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL	American Micro Scan	1986-09-11	62	0
K862332	ANAEROBE RAPID CHROMOGENIC ID PANEL	American Micro Scan	1986-08-27	69	0
K862140	MICRODILUTION PANELS	American Micro Scan	1986-07-16	42	4
K861584	GRAM NEGATIVE COMBO PANEL TYPE 3	American Micro Scan	1986-06-17	49	0
K860575	YEAST IDENTIFICATION PANEL	American Micro Scan	1986-05-13	84	0
K854278	NEG COMBO BREAKPOINT PANEL POS COMBO	American Micro Scan	1986-03-04	131	0
K854447	IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST	American Micro Scan	1986-01-03	59	0
K854490	IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES	American Micro Scan	1985-12-27	45	0
K852976	NEG COMBO PANELS, NEG/URI MIC,NEG ID,POS MIC	American Micro Scan	1985-12-04	142	0
K854448	AUTOSCAN W/A SYSTEM	American Micro Scan	1985-11-26	21	0
K844086	POS COMBO PANEL	American Micro Scan	1984-11-13	22	0
K842947	MICROBIOLOGICAL TRAY READER-MANUAL	American Micro Scan	1984-09-14	50	0
K842874	RADIOMETRIC BLOOD CULTURE VIALS, AEROBE	American Micro Scan	1984-09-12	51	0
K833027	HAEMOPHILUS/NEISSERIA IDENTIF-PANEL	American Micro Scan	1983-10-28	51	0
K831058	SAF FIXATIVE	American Micro Scan	1983-06-08	68	0
K831060	TRICHROME STAIN	American Micro Scan	1983-06-08	68	0
K831061	PVA FIXATIVE/FORMALIN	American Micro Scan	1983-06-08	68	0
K831059	P & T MEDIUM	American Micro Scan	1983-04-28	27	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda