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

Technicon Instruments Corp. — Predicate Candidate Screening

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

39 daysmedian FDA review time

99 days90th percentile

157clearances measured

K-number	Device	Applicant	Decided	Review days
K914511	TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL	Technicon Instruments Corp.	1991-11-27	49
K914888	TECHNICON CHEM 1(TM) SYST (GEN2 SYST)	Technicon Instruments Corp.	1991-11-27	28
K914025	TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P)	Technicon Instruments Corp.	1991-11-22	74
K912616	TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES	Technicon Instruments Corp.	1991-09-25	104
K912413	CHEM-LINK DATA BASE MANAGER	Technicon Instruments Corp.	1991-07-01	31
K903305	TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD	Technicon Instruments Corp.	1990-09-27	65
K903825	DRUG OF ABUSE ANALYSIS SYSTEM	Technicon Instruments Corp.	1990-09-27	38
K903824	DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY	Technicon Instruments Corp.	1990-09-27	38
K903306	TECHNICON CHEM I SYSTEM MAGNESIUM METHOD	Technicon Instruments Corp.	1990-08-29	36
K901410	TECHNICON RA-2000(TM) SYSTEM	Technicon Instruments Corp.	1990-07-17	113
K902243	TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES	Technicon Instruments Corp.	1990-07-05	48
K901124	CHEM I CLINICAL ANALYZER URINE MAGNESIUM	Technicon Instruments Corp.	1990-05-14	63
K901123	CHEM 1 CLINICAL ANALYZER URINE UREA NITROGEN	Technicon Instruments Corp.	1990-05-10	59
K901229	CHEM 1 CLINICAL ANALYZER (METHOD URINE CREATININE)	Technicon Instruments Corp.	1990-05-04	51
K900717	TECHNICON TESTPOINT(TM) LIGAND CONTROL	Technicon Instruments Corp.	1990-04-26	71
K900943	MODIFIED TECHNICON DPA-1(TM) SYSTEM	Technicon Instruments Corp.	1990-04-26	57
K901693	TECHNICON CHEM 1 CLINICAL ANALYZER FOR URINE URIC	Technicon Instruments Corp.	1990-04-25	14
K901226	CHEM 1 CLINICAL ANALYZER (METHOD URINE CALCIUM)	Technicon Instruments Corp.	1990-04-19	36
K901137	CHEM 1 CLINICAL ANALYZER (URINE INORGANIC PHOSPHO)	Technicon Instruments Corp.	1990-04-12	31
K900905	TECHNICON AXON SYSTEM REAGENT METHODS	Technicon Instruments Corp.	1990-04-03	35
K901122	TECHNICON CHEM 1 CLINICAL ANALYZER URINE GLUCOSE	Technicon Instruments Corp.	1990-03-29	17
K900593	TECHNICON H*2(TM) SYSTEM	Technicon Instruments Corp.	1990-03-14	35
K896829	TECHNICON RA SYSTEMS SODIUM (COLORIMETRIC METHOD)	Technicon Instruments Corp.	1990-02-23	81
K895664	TECHNICON DAX SYSTEM - POTASSIUM (ISE) METHOD	Technicon Instruments Corp.	1989-11-14	55
K895672	TECHNICON DAX SYSTEM - SODIUM (ISE) METHOD	Technicon Instruments Corp.	1989-10-25	35
K895808	TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN	Technicon Instruments Corp.	1989-10-17	15
K894575	TECHNICON RA SYSTEM THYROXINE T4 METHOD	Technicon Instruments Corp.	1989-10-04	75
K893913	TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD	Technicon Instruments Corp.	1989-08-21	83
K893912	TECHNICON RA SYSTEMS GENTAMICIN TEST METHOD	Technicon Instruments Corp.	1989-08-21	83
K894574	TECHNICON DPA-1 SYSTEM RF METHOD	Technicon Instruments Corp.	1989-08-10	20
K892930	TECHNICON DAX TM SYSTEM ADDITIONAL ANALYTES	Technicon Instruments Corp.	1989-07-27	97
K892929	TECHNICON AXON TM SYSTEM ADDITIONAL ANALYTES	Technicon Instruments Corp.	1989-07-20	90
K892198	TECHNICON DPA-1 (TM) CRP METHOD	Technicon Instruments Corp.	1989-05-09	36
K885203	TECHNICON DAX(TM) SYSTEM	Technicon Instruments Corp.	1989-03-28	99
K885226	TECHNICON AXON(TM) SYSTEM	Technicon Instruments Corp.	1989-02-17	59
K884748	TECHNICON CHEM 1 SYSTEM ACID PHOS (PROSTATIC)	Technicon Instruments Corp.	1989-01-30	77
K884747	TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL)	Technicon Instruments Corp.	1989-01-30	77
K884599	TECHNICON RA-100 SYSTEM CALCIUM METHOD	Technicon Instruments Corp.	1989-01-27	85
K884601	TECHNICON SYSTEMS RA-100/ASSIST CHLORIDE	Technicon Instruments Corp.	1989-01-27	85
K884600	TECHNICON SYSTEM RA-100/ASSIST MAGNESIUM	Technicon Instruments Corp.	1989-01-23	81
K883586	TECHNICON RA-100 SYSTEM POTASSIUM	Technicon Instruments Corp.	1988-11-29	98
K883585	TECHNICON ASSIST POTASSIUM	Technicon Instruments Corp.	1988-11-29	98
K884433	TECHNICON ASSIST(R) CALCIUM METHOD	Technicon Instruments Corp.	1988-11-29	39
K884419	TECHNICON RA-PHENOBARBITAL	Technicon Instruments Corp.	1988-11-22	33
K884217	TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN	Technicon Instruments Corp.	1988-11-04	23
K883104	CHEM 1 UIBC (IRON BINDING CAPACITY TEST)	Technicon Instruments Corp.	1988-10-25	92
K883326	TECHNICON RA(TM) SYSTEMS - MAGNESIUM	Technicon Instruments Corp.	1988-10-13	66
K883493	TECHNICON DPA-1 IMMUNOGLOBULIN M	Technicon Instruments Corp.	1988-09-22	37
K883492	TECHNICON DPA-1 IMMUNOGLOBULIN A	Technicon Instruments Corp.	1988-09-22	37
K883209	TECHNICON RA-100(TM) SYSTEM	Technicon Instruments Corp.	1988-09-13	46

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