Micromedic Systems

Walker, MI, US

Micromedic Systems appears in FDA device records in Walker, MI. FDA records list 42 510(k) clearances between 1976-07-20 and 1993-03-31, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 42
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

FDA records hold 42 510(k) clearances for Micromedic Systems between 1976 and 1993. The busiest year on record is 1979, with 9. The most recent is 1993, with 1.

Clearances by year, as a table

510(k) clearance decisions for Micromedic Systems, by decision year
Year	Clearances
1976	1
1978	2
1979	9
1980	3
1981	4
1982	5
1983	3
1984	4
1985	1
1986	4
1987	5
1993	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K923643	MEDICOOL	ILO	Substantially Equivalent	1993-03-31
K872309	MICROMEDIC COMBOSTAT LH/FSH KIT	CGJ	Substantially Equivalent	1987-07-31
K871505	AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT	JLW	Substantially Equivalent	1987-05-26
K871008	MICROMEDIC NEONATAL T4 KIT	CDX	Substantially Equivalent	1987-05-26
K870904	MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KIT	JLW	Substantially Equivalent	1987-05-26
K870245	AUTOPAK TSH MONOCLONAL IRMA KIT	JLW	Substantially Equivalent	1987-04-01
K862206	TAURUS (TM) AUTOMATIC LIQUID SCINTILLATION COUNTER	JJJ	Substantially Equivalent	1986-08-04
K860813	MICROMEDIC HTSH MONOCLONAL IRMA KIT	JLW	Substantially Equivalent	1986-07-14
K861262	MMS T3 UPTAKE	KHQ	Substantially Equivalent	1986-05-23
K861320	MMS T4 RIA KIT	CDX	Substantially Equivalent	1986-04-24
K853127	MICROMEDIC COMBOSTAT B B12/FOLATE(BOIL)	CDD	Substantially Equivalent	1985-09-16
K842902	MICROSTAT GAMMA COUNTER	JJJ	Substantially Equivalent	1984-08-09
K840938	HIGH SPEED DISPENSER	JQW	Substantially Equivalent	1984-04-19
K840188	MICROMEDIC LH & FSH RIA KIT	CEP	Substantially Equivalent	1984-03-23
K834590	ACCUFLEX	JQW	Substantially Equivalent	1984-03-19
K832462	AUTOPAK NEONATAL TSH RIA KIT	JLW	Substantially Equivalent	1983-09-12
K831264	BHCG RIA KIT	JHI	Substantially Equivalent	1983-06-08
K830157	DIGIFLEX AUTOMATIC PIPETTE	JQW	Substantially Equivalent	1983-03-10
K823275	AUTOPAK FERRITIN TEST DELIVERY SYS	DBF	Substantially Equivalent	1982-12-03
K822578	MICROMEDIC ESTRIOL RIA KIT	CGI	Substantially Equivalent	1982-10-26
K821678	AUTOPAK ESTRIOL TEST DELIVERY SYSTEM	CGI	Substantially Equivalent	1982-06-24
K820376	MICROMEDIC SYSTEMS ISOFLEX	JJJ	Substantially Equivalent	1982-03-16
K813645	MICROMEDIC HTSH RIA KIT	JLW	Substantially Equivalent	1982-01-22
K813525	IN VITRO DIAGNOSTIC RADIOIMMUNOASSAY	JLW	Substantially Equivalent	1981-12-31
K811808	AUTOPAK-12 FERRITIN KIT	DBF	Substantially Equivalent	1981-07-10
K810186	MICROMEDIC SYSTEMS' AUTOPAK	CGN	Substantially Equivalent	1981-02-04
K803252	MICROMEDIC REAGENT DISPENSER	JTC	Substantially Equivalent	1981-01-12
K800606	MICROMEDIC AUTOMATIC DILUTER	JQW	Substantially Equivalent	1980-04-16
K800075	MICROMEDIC PUNCH & ELUTER	JQW	Substantially Equivalent	1980-02-13
K792662	AUTOPAK-12 UPTAKE TEST DELIVERY SYSTEM	KHQ	Substantially Equivalent	1980-01-17
K792279	AUTOPAK 12 INSULIN TEST DELIVERY SYSTEM	CFP	Substantially Equivalent	1979-12-06
K791375	AUTOPAK 12 T3 RIA TEST DELIVERY SYSTEM	CDP	Substantially Equivalent	1979-10-11
K790347	AUTO PAK VITAMIN B-12	CDD	Substantially Equivalent	1979-09-27
K791324	MICROMEDIC APS2	JQW	Substantially Equivalent	1979-08-28
K791325	AUTOPAK 12 DIGOXIN TEST DELIVERY SYSTEM	DPO	Substantially Equivalent	1979-08-16
K790907	AUTOPAK TEST DELIVERY SYSTEM	CDX	Substantially Equivalent	1979-06-27
K790906	AUTOPAK CORTISOL TEST DELIVERY SYSTEM	CGR	Substantially Equivalent	1979-06-27
K790665	NEONATAL TY AUTOPAK TEST DELIVERY SYSTEM	CDX	Substantially Equivalent	1979-05-15
K790260	NTSH AUTOPAK TEST DELIVERY SYSTEM	JLW	Substantially Equivalent	1979-03-21
K781086	INSULIN AUTOPAK	CFP	Substantially Equivalent	1978-08-14
K780383	COUNTER, RADIOASSAY, AUTO., MICROMEDIC	JJJ	Substantially Equivalent	1978-03-22
K760006	RADIOASSAY, CONCEPT 4		Substantially Equivalent	1976-07-20

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain