510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Pro-Lab, Inc.

Mchenry, IL, US

Pro-Lab, Inc. appears in FDA device records in Mchenry, IL. FDA records list 27 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
27
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 27 510(k) clearances for Pro-Lab, Inc. between 1984 and 1995. The busiest year on record is 1985, with 9. The most recent is 1995, with 1.

Clearances by year, as a table
510(k) clearance decisions for Pro-Lab, Inc., by decision year
YearClearances
19846
19859
19863
19872
19882
19891
19911
19921
19931
19951
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K934383PROLEX (STREPTOCCAL GROUPING LATEX KIT)GTZSubstantially Equivalent
K914419AMNIOTEST(TM)HIOSubstantially Equivalent
K921421LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODYLHLSubstantially Equivalent
K903714E. COLI 0157 LATEX TESTGNASubstantially Equivalent
K894221ROSCO PYRRJTOSubstantially Equivalent
K883996X-ACT LDC/INDJSESubstantially Equivalent
K883995X-ACT UREA/TDAJSESubstantially Equivalent
K871121PROTECT T.M.JTRSubstantially Equivalent
K870117NEISSERIA/BRANHAMELLA DIFFERENTIAL TESTJSXSubstantially Equivalent
K861142MASTER KIT BLRPUnknown
K861889D'ALA RAPID TESTJTOSubstantially Equivalent
K861888HIPPURATE HYDROLYSIS TESTJTOSubstantially Equivalent
K850246MASTER KIT ASubstantially Equivalent
K850302SUPLEX & SUPLEX DILUENTJSKSubstantially Equivalent
K850308C.L.A.T.JSKSubstantially Equivalent
K850307CAMPYLOBACTER SUPPLEMENT-BLASER/WANGJSKSubstantially Equivalent
K850306CAMPYLOBACTER SUPPLEMENT -SKIRROWJSKSubstantially Equivalent
K850301YEAST DIALYSATEJSKSubstantially Equivalent
K850300MUCOLYSEJSKSubstantially Equivalent
K850299C.N.V.T.JSKSubstantially Equivalent
K850072CUSTOM OPEN HEART TRAYSubstantially Equivalent
K843813INTRAVENOUS START KITSubstantially Equivalent
K843627VENESECTION TRAY, ADULT 6050FSMSubstantially Equivalent
K842404DRESSING CHANGE TRAY STERILE 5002Substantially Equivalent
K843525SUTURE TRAYSubstantially Equivalent
K843982O.B. BASIN SETFRGSubstantially Equivalent
K842405DR. GOULD HAND PACK SUSTOM STERILFRGSubstantially Equivalent

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 Pro-Lab, Inc. 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 Pro-Lab, Inc.. 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 , FDA export datePage updated Source: openFDA, public domain