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

Micromedic Systems — Predicate Candidate Screening

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

45 daysmedian FDA review time

81 days90th percentile

42clearances measured

K-number	Device	Applicant	Decided	Review days
K923643	MEDICOOL	Micromedic Systems	1993-03-31	253
K872309	MICROMEDIC COMBOSTAT LH/FSH KIT	Micromedic Systems	1987-07-31	45
K871008	MICROMEDIC NEONATAL T4 KIT	Micromedic Systems	1987-05-26	74
K871505	AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT	Micromedic Systems	1987-05-26	39
K870904	MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KIT	Micromedic Systems	1987-05-26	82
K870245	AUTOPAK TSH MONOCLONAL IRMA KIT	Micromedic Systems	1987-04-01	70
K862206	TAURUS (TM) AUTOMATIC LIQUID SCINTILLATION COUNTER	Micromedic Systems	1986-08-04	55
K860813	MICROMEDIC HTSH MONOCLONAL IRMA KIT	Micromedic Systems	1986-07-14	132
K861262	MMS T3 UPTAKE	Micromedic Systems	1986-05-23	49
K861320	MMS T4 RIA KIT	Micromedic Systems	1986-04-24	16
K853127	MICROMEDIC COMBOSTAT B B12/FOLATE(BOIL)	Micromedic Systems	1985-09-16	53
K842902	MICROSTAT GAMMA COUNTER	Micromedic Systems	1984-08-09	17
K840938	HIGH SPEED DISPENSER	Micromedic Systems	1984-04-19	45
K840188	MICROMEDIC LH & FSH RIA KIT	Micromedic Systems	1984-03-23	65
K834590	ACCUFLEX	Micromedic Systems	1984-03-19	81
K832462	AUTOPAK NEONATAL TSH RIA KIT	Micromedic Systems	1983-09-12	48
K831264	BHCG RIA KIT	Micromedic Systems	1983-06-08	51
K830157	DIGIFLEX AUTOMATIC PIPETTE	Micromedic Systems	1983-03-10	51
K823275	AUTOPAK FERRITIN TEST DELIVERY SYS	Micromedic Systems	1982-12-03	30
K822578	MICROMEDIC ESTRIOL RIA KIT	Micromedic Systems	1982-10-26	62
K821678	AUTOPAK ESTRIOL TEST DELIVERY SYSTEM	Micromedic Systems	1982-06-24	16
K820376	MICROMEDIC SYSTEMS ISOFLEX	Micromedic Systems	1982-03-16	35
K813645	MICROMEDIC HTSH RIA KIT	Micromedic Systems	1982-01-22	22
K813525	IN VITRO DIAGNOSTIC RADIOIMMUNOASSAY	Micromedic Systems	1981-12-31	15
K811808	AUTOPAK-12 FERRITIN KIT	Micromedic Systems	1981-07-10	15
K810186	MICROMEDIC SYSTEMS' AUTOPAK	Micromedic Systems	1981-02-04	13
K803252	MICROMEDIC REAGENT DISPENSER	Micromedic Systems	1981-01-12	20
K800606	MICROMEDIC AUTOMATIC DILUTER	Micromedic Systems	1980-04-16	30
K800075	MICROMEDIC PUNCH & ELUTER	Micromedic Systems	1980-02-13	30
K792662	AUTOPAK-12 UPTAKE TEST DELIVERY SYSTEM	Micromedic Systems	1980-01-17	22
K792279	AUTOPAK 12 INSULIN TEST DELIVERY SYSTEM	Micromedic Systems	1979-12-06	23
K791375	AUTOPAK 12 T3 RIA TEST DELIVERY SYSTEM	Micromedic Systems	1979-10-11	79
K790347	AUTO PAK VITAMIN B-12	Micromedic Systems	1979-09-27	218
K791324	MICROMEDIC APS2	Micromedic Systems	1979-08-28	43
K791325	AUTOPAK 12 DIGOXIN TEST DELIVERY SYSTEM	Micromedic Systems	1979-08-16	35
K790906	AUTOPAK CORTISOL TEST DELIVERY SYSTEM	Micromedic Systems	1979-06-27	47
K790907	AUTOPAK TEST DELIVERY SYSTEM	Micromedic Systems	1979-06-27	47
K790665	NEONATAL TY AUTOPAK TEST DELIVERY SYSTEM	Micromedic Systems	1979-05-15	39
K790260	NTSH AUTOPAK TEST DELIVERY SYSTEM	Micromedic Systems	1979-03-21	43
K781086	INSULIN AUTOPAK	Micromedic Systems	1978-08-14	46
K780383	COUNTER, RADIOASSAY, AUTO., MICROMEDIC	Micromedic Systems	1978-03-22	13
K760006	RADIOASSAY, CONCEPT 4	Micromedic Systems	1976-07-20	43

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