Diagnostic Chemicals, Ltd. (USA)

Laguna Hills, CA, US

Diagnostic Chemicals, Ltd. (Usa) appears in FDA device records in Laguna Hills, CA. FDA records list 77 510(k) clearances between 1984-05-30 and 2002-08-23, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 77
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

Showing 50 of 77

FDA records hold 77 510(k) clearances for Diagnostic Chemicals, Ltd. (USA) between 1984 and 2002. The busiest year on record is 1984, with 33. The most recent is 2002, with 1.

Clearances by year, as a table

510(k) clearance decisions for Diagnostic Chemicals, Ltd. (USA), by decision year
Year	Clearances
1984	33
1985	7
1986	6
1987	1
1988	17
1989	2
1990	3
1991	2
1993	3
1994	1
1998	1
2002	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K022538	IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25	JIR	Substantially Equivalent	2002-08-23
K974874	BILIRUBIN-SL (TOTAL) ASSAY	CIG	Substantially Equivalent	1998-02-12
K932556	AMMONIA ASSAY CAT. NO. 200-02	JIF	Substantially Equivalent	1994-08-02
K932766	HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)	LBR	Substantially Equivalent	1993-12-10
K932555	DC-LINEATE CAT. NO. SE-091	JIS	Substantially Equivalent	1993-08-19
K925877	DC-UIBC-CAL	JIS	Substantially Equivalent	1993-03-18
K912825	MAGNESIUM ASSAY KIT, CAT.# 100-12	JGJ	Substantially Equivalent	1991-07-26
K895964	DCL SYPHILIS-M CATALOG NO. 600-80	LIP	Substantially Equivalent	1991-01-08
K895965	DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70	LIP	Substantially Equivalent	1990-12-26
K904660	ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14	JFM	Substantially Equivalent	1990-11-20
K901510	ENZYMATIC THEOPHYLLINE REAGENT, #500-82	KLS	Substantially Equivalent	1990-06-12
K895873	CALCIUM, CATALOGUE NUMBER140-20	CJY	Substantially Equivalent	1989-12-12
K885097	ACETAMINOPHEN (ENZYMATIC RATE), NUMBER 502-13	LDP	Substantially Equivalent	1989-01-11
K883148	IMMUKNOW-CHECK HCG ASSAY KIT, CAT. #900-40	DHA	Substantially Equivalent	1988-12-05
K880868	CARBON DIOXIDE ASSAY KIT (ENZYMATIC) 201-18/202-18	KHS	Substantially Equivalent	1988-11-01
K882258	DC-LIQUICAL CATALOGUE #SE-030	JIX	Substantially Equivalent	1988-08-30
K882259	DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023	JIT	Substantially Equivalent	1988-07-21
K880692	ASPARTATE AMINOTRANSFERASE ASSAY KIT (IFCC)	CIT	Substantially Equivalent	1988-05-27
K880866	CARBON DIOXIDE ASSAY KIT(ENZY. SINGLE) 203-10	KHS	Substantially Equivalent	1988-04-28
K880867	AMYLASE 405 CATALOG NUMBER 301-34	JFJ	Substantially Equivalent	1988-04-19
K881054	CALCIUM, CATALOGUE NUMBER 122-20	CIC	Substantially Equivalent	1988-04-18
K875211	GLUCOSE (TRINDER) CAT. # 220-32	CGA	Substantially Equivalent	1988-04-18
K875208	CHLORIDE CAT. # 152-17	CHJ	Substantially Equivalent	1988-04-18
K875207	ALBUMIN CAT. # 201-03	CIX	Substantially Equivalent	1988-04-18
K874496	CALCIUM ASSAY KIT, NUMBER 120-19	CIC	Substantially Equivalent	1988-02-11
K875210	ALKALINE PHOSPHATASE CAT. # 306-22, 306-23	CJE	Substantially Equivalent	1988-02-02
K875206	LACTATE DEHYDROGENASE CAT. # 320-68, 320-69	CFJ	Substantially Equivalent	1988-02-02
K875209	ACID PHOSPHATASE (KINETIC) CAT. # 320-06	CKB	Substantially Equivalent	1988-02-01
K874284	SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM	JHT	Substantially Equivalent	1988-01-21
K874772	DC-TROL LEVEL 1 OR 2	JJY	Substantially Equivalent	1988-01-05
K870336	SALICYLATE ASSAY KIT, CATALOGUE NUMBER 501-71	DKJ	Substantially Equivalent	1987-02-20
K862834	MODEL 115-16 PHOSPHORUS (UV) ASSAY KIT	CEO	Substantially Equivalent	1986-08-19
K862833	MODEL 303-47/303-48 ALANINE AMINOTRANSFERASE KIT	CKA	Substantially Equivalent	1986-08-19
K862832	MODEL 303-42/303-43 ASPARTATE AMINOTRANSFERASE KIT	CIT	Substantially Equivalent	1986-08-12
K861095	BILIRUBIN ASSAY KIT (TOTAL), CATA. NUMBER 202-04	CIG	Substantially Equivalent	1986-04-21
K861094	BILIRUBIN ASSAY KIT (DIRECT), CATA. NUMBER 202-02	CIG	Substantially Equivalent	1986-04-21
K860625	GLUCOSE HK-60 ASSAY KIT CAT. #201-39	CFR	Substantially Equivalent	1986-03-17
K853102	UREASE & GLUTAMATE DEHYDROGENASE, UREA NITROGEN	CDQ	Substantially Equivalent	1985-08-02
K852753	DC LIQUITROL LEVEL 1 & 2	JJY	Substantially Equivalent	1985-08-02
K852636	X-AMYLASE ASSAY KIT	CIJ	Substantially Equivalent	1985-07-12
K852595	DC-3 FLUIDS PACK, DC-5 FLUIDS PACK	JGS	Substantially Equivalent	1985-07-12
K852594	DC-LIP, CATALOGUE NUMBER SE-020	JJY	Substantially Equivalent	1985-07-12
K852058	CHLORIDE ASSAY KIT	CHJ	Substantially Equivalent	1985-07-12
K850788	GLUTAMYLTRANSFERASE ASSAY KIT	JPZ	Substantially Equivalent	1985-03-19
K842158	SALICYLATE ASSAY KIT	DKJ	Substantially Equivalent	1984-10-22
K843536	TRIGLYCERIDE ASSAY KIT GPO-CP	CDT	Substantially Equivalent	1984-10-11
K842873	STANDARDS & ACCESSORIES FOR NOVA INSTRU	JGS	Substantially Equivalent	1984-10-05
K843379	VMA ASSAY KIT	CDF	Substantially Equivalent	1984-09-28
K843377	CREATININE ASSAY KIT	CGX	Substantially Equivalent	1984-09-28
K843380	ACID PHOSPHATASE ASSAY KIT	CKE	Substantially Equivalent	1984-09-20

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

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Diagnostic Chemicals, Ltd. (USA) edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Diagnostic Chemicals, Ltd. (USA). The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.

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